Safety and Efficacy Evaluation of the Mosaic Ultra Device
Phase: NA
Conditions: Skin Texture Disorder, Photoaging, Wrinkle, Scar, Stretch Mark, Acne Vulgaris, Hair Loss
Sponsor: CynosureLutronic

 
CLINICAL PROTOCOL NUMBER: LMI22001 
 
SAFETY AND EFFICACY EVALUATION OF THE MOSAIC ULTRA DEVICE 
Sponsor: Lutronic Global 
 
DATE: AUGUST 4, 2023 
Draft or version number: 1.4 
 
Confidential – Proprietary Information 
 
 
 

 
 
Protocol Number: LMI22001 Mosaic Ultra v1.4 
 
Page 2 of 40 
CONFIDENTIAL 
 
LUTRONIC AESTHETICS GLOBAL 
 
 
 
 
 
 
 
 
 
 
 
SPONSOR STATEMENT AND SIGNATURE PAGE 
Company Name:  
 
Lutronic Global 
Address: 
 
 
Lutronic Global 
Address: 
 
 
19 Fortune Drive 
 
 
 
 
Billerica, MA 01821 
Telephone: 
 
 
888-588-7644 
Study Devices: 
 
 
Mosaic Ultra  
Protocol Title: 
Safety and Efficacy of the Mosaic Ultra Device 
 
Protocol Number: 
LMI22001 
Original Protocol / Date:  
10/17/2022 
Final Protocol Version / Date: 
6/1/2022 
The investigation will be conducted in compliance with this clinical investigation plan (CIP), Good Clinical Practice 
(GCP) guidelines, including EN ISO 14155, the Declaration of Helsinki, and regulatory authority requirements. 
 
Lutronic, Inc. (hereinafter “Study Sponsor”) maintains responsibility for the ongoing safety of this clinical trial 
involving the evaluation of the DermaV Laser System. Study Sponsor will promptly notify all investigators, the 
responsible IRB(s), and the regulatory authorities of any findings from ongoing trial monitoring activities that could 
adversely affect the safety of participants, impact the conduct of the clinical study, or alter the IRB’s approval to 

 
 
Protocol Number: LMI22001 Mosaic Ultra v1.4 
 
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LUTRONIC AESTHETICS GLOBAL 
 
 
continue the study, specifically within five working days of making an Unanticipated Adverse Device Effect (UADE) 
determination or 15 working days after first receiving notice of the UADE, within 10 days for Serious Adverse Event 
reports, and at least annually for routine reports. In the event that participant safety could be directly affected by 
study results after the study has ended, Study Sponsor will notify all investigators of these results to enable 
investigators to consider informing participants as soon as possible or at least within one year of study closure.   
The following individuals are responsible for the content of the Clinical Investigational Plan: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Paul Cardarelli 
 
 
 
 
 
 
Date 
Director, Clinical Affairs 
 
 
 
 
 
 
 

 
 
Protocol Number: LMI22001 Mosaic Ultra v1.4 
 
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LUTRONIC AESTHETICS GLOBAL 
 
 
SPONSOR CONTACT INFORMATION 
 
Protocol Title: 
Safety and Efficacy of the Mosaic Ultra Device 
Protocol Number: 
 
LMI22001 
Sponsor: 
 
 
Lutronic Global 
 
 
 
 
19 Fortune Dr. 
 
 
 
 
Billerica, MA 01821 
 
Lutronic Contact Information: 
Paul Cardarelli 
 
 
 
 
Exec. Director, Clinical Affairs 
 
 
 
 
Phone: (978) 697-8783 
 
 
 
 
Email: pcardarelli@lutronic.com 
 
Site Contact Information:  
 
Site 1 :   
 
 
Medical Director, Principal Investigator 
 
 
 
 
Omar A. Ibrahimi, M.D., Ph.D. 
19 Fortune Dr. 
 
 
 
 
Billerica, MA 01821 
Email: omar.ibrahimi@gmail.com 
Tel: (203) 428-4440 
Fax: (203) 890-9449 
 
Site 2 :   
 
 
Principal Investigator 
 
 
 
 
Robert D. Murgia III, D.O. 
23 Centennial Drive 
 
 
 
 
Peabody, MA 01960 
Email: drmurgia@gmail.com 
Tel: (978)525-0100 
 
Site 3 :   
 
 
Principal Investigator 
 
 
 
 
Amy Forman Taub, MD, FAAD 
275 Parkway Drive, Suite 521  
Lincolnshire, IL 60069 
Email: drtaub@advdermatology.com 
Tel: (847)459-4610 
 
 
 
 
 
 
 
 
 

 
 
Protocol Number: LMI22001 Mosaic Ultra v1.4 
 
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LUTRONIC AESTHETICS GLOBAL 
 
 
STATEMENT OF COMPLIANCE 
I have thoroughly read and reviewed this clinical investigation plan (CIP) and hereby agree to participate in this clinical trial 
sponsored by Study Sponsor. I agree to conduct this investigation according to the requirements of the CIP provided by the 
Study Sponsor; and in accordance with Good Clinical Practice (GCP), as required by EN ISO 14155, the Declaration of Helsinki; 
Investigational Device Exemption (21 CFR Part 812); Protection of Human Subjects (45 CFR Part 46); and other applicable 
FDA regulations; and regulations of other relevant regulatory authorities; and conditions imposed by the reviewing 
Institutional Review Board (IRB) or Ethics Committee (EC). Except where necessary to eliminate an immediate hazard(s) to 
the trial participants, I agree that no deviation from, or changes to the CIP, will take place without prior agreement from the 
sponsor and documented approval from the Institutional Review Board (IRB). I agree to ensure that appropriate informed 
consent is obtained from all participants prior to inclusion in this study. I also agree to supervise all testing of the device 
involving human participants, and to report to the Study Sponsor, within 24 hours, any adverse event that is serious, whether 
considered treatment-related or not. I am aware that the Study Sponsor reserves the right to discontinue this investigation 
at any time. 
I understand that this investigation will be monitored by the Study Sponsor and/or a designee contracted or employed by 
the Study Sponsor. This monitoring will involve periodic inspection of my investigational site and ongoing review of the data 
that is submitted by me to the Study Sponsor. I am also aware that I may be inspected by a representative of the relevant 
regulatory authorities, including the United States Food and Drug Administration, to verify compliance with applicable 
regulations related to clinical research on human participants. 
My current curriculum vitae and the curriculum vitae of physicians/licensed practitioners at this institution who will 
participate as co-investigators/sub-investigators in this study will be provided to the Study Sponsor. This curriculum vitae 
will include the extent and type of our relevant experience with pertinent dates and locations. All personnel involved in the 
conduct of this study have completed Human Subjects Protection Training. 
I certify that I have not been involved in an investigation that was terminated for non-compliance at the insistence of the 
Study Sponsor, the IRB or EC, or other regulatory authorities. I agree to provide the Study Sponsor sufficient, accurate 
financial disclosure information.  I also agree to update financial disclosure information if any relevant changes occur during 
the investigation and for one year following the completion of the study. 
I understand that this CIP and the trial results are confidential, and I agree not to disclose any such information to any person 
other than a representative of the Study Sponsor or the relevant competent authorities without the prior written consent 
of the Study Sponsor. 
Accepted by: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Principal Investigator Signature 
 
 
Principal Investigator Name 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Co-/Sub-Investigator Signature 
 
 
Co-/Sub-Investigator Name 
 
 
 
Date 
 
 
  
 
 
 

 
 
Protocol Number: L20001 DermaV v1.8 
 
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LUTRONIC AESTHETICS GLOBAL 
 
LIST OF ABBREVIATIONS 
TERM 
DEFINITION 
TERM 
DEFINITION 
AE 
Adverse Event 
ICH E6 
International Conference on 
Harmonization Guidance for Industry, 
Good Clinical Practice: Consolidated 
Guidance  
ADE 
Adverse Device Effect 
ICMJE 
International Committee of Medical 
Journal Editors  
ANCOVA 
Analysis of Covariance 
IDE  
Investigational Device Exemption 
BMI 
Body Mass Index 
IFU 
Instructions for Use 
CFR 
Code of Federal Regulations 
IPL 
Intense Pulse Light 
CGAIS 
Clinician Global Aesthetic Improvement 
Scale 
ISO 
International Organization for 
Standardization 
CIP 
Clinical Investigation Plan 
IRB 
Institutional Review Board 
CMP 
Clinical Monitoring Plan 
MOP 
Manual of Procedures 
CRF 
Case Report Form 
NRS 
Numeric Rating Scale for pain 
assessment 
CRO 
Contract Research Organization 
OHRP 
Office for Human Research Protections 
CV 
Curriculum Vitae 
PI 
Principal Investigator 
DCC 
Data Coordination Center 
PSQ 
Patient Satisfaction Questionnaire 
DSMB 
Data Safety Monitoring Board 
QA 
Quality Assurance 
EC 
Ethics Committee 
QC 
Quality Control 
eCRF 
Electronic Case Report Form 
SAE 
Serious Adverse Event 
ETE 
Expected Treatment Effect 
SAP 
Statistical Analysis Plan 
FDA 
Food and Drug Administration 
SADE 
Serious Adverse Device Effect 
FDAAA 
Food and Drug Administration 
Amendments Act of 2007 
SGAIS 
Subject Global Aesthetic Improvement 
Scale 
GAIS 
Global Aesthetic Improvement Scale 
SMC 
Safety Monitoring Committee 
GCP 
Good Clinical Practice 
SOP 
Standard Operating Procedure 
GLP 
Good Laboratory Practice 
UADE 
Unanticipated  Adverse Device Effect 
GMP 
Good Manufacturing Practice 
USA 
United States of America 
HIPAA 
Health Information Portability and 
Accountability Act 
CGAIS 
Clinical Global Aesthetic Improvement 
Scale 
IB 
Investigator’s Brochure 
 
 
ICH 
International Committee on 
Harmonization 
 
 
 
 
 

CONFIDENTIAL – PROPRIETARY INFORMATION 
 
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PROTOCOL SYNOPSIS 
Protocol Number: 
LMI22001 
Protocol Title: 
Safety and Efficacy of the Mosaic Ultra Device 
Investigational 
Devices: 
Mosaic Ultra 
Development Phase: 
Pilot 
Study Objective: 
Evaluate the Safety and Efficacy of the Mosaic Ultra 1550nm system for the treatment 
of skin tone and texture, facial rejuvenation, photoaging, wrinkles, scars, stretch marks, 
acne vulgaris and hair loss. 
Brief Study Overview: 
Prospective, Multi-Site, Non-Randomized study of up to 210 participants in two 
treatment groups 
• 
Group A:  Clinical Treatment Arm (n=180) 
• 
Group B: Biopsy Arm (n=30) 
 
Subject’s in Group A will be treated with the device with the recommended parameters 
based on pre-clinical testing and similar device parameters.  Subjects will receive up to 
5 treatments and then attend follow-ups 30 and 90-days post treatment.  Subject’s may 
be asked to participate in an optional biopsy portion of this arm 
 
Subject’s in group B will be treated at pre-determined parameters based on regulatory 
body requirements.  Subjects will return up to 3 months post treatment.  5 Biopsies will 
be collected prior to treatment and throughout the follow-up periods. 
Number of Sites 
Enrolling Participants: 
3 sites located in the United States 
Sample Size:  
N = up to 210 treated participants 
Participant 
Population: 
Healthy adults, male and female, at least 18 years old who meet the inclusion and 
exclusion criteria. 
Inclusion Criteria:  
• 
Non-smoking, Male or Female 
• 
Age 18 – 60 years old  
• 
Understands and accepts the obligation not to undergo any other procedures 
in the areas to be treated. 
• 
Participants who are willing and able to comply with all study participation 
requirements including returning for follow-up visits and abstaining from 
exclusionary procedures for the duration of the study. 
• 
OPTIONAL - Participants who are willing to undergo biopsies. 
Exclusion Criteria: 
• 
Previous surgical or cosmetic procedure to the target area in the last 6 to 12 
months that could interfere with the treatment procedure 
• 
A study participant must not be pregnant or have been pregnant in the last 3 
months  
• 
A recent history of smoking (6 months)  
• 
Presence of an active skin disease or condition that may affect wound healing 
(ie. diabetes myelitis; connective tissue disease; radiation therapy; or 
chemotherapy) 
• 
Seizure disorder caused by bright light 
• 
A history of thrombophlebitis 
• 
A history of acute infections 
• 
A history of heart failure 

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• 
Cancer, malignant disease, skin pathology, condition, or allergic reactions that 
could interfere with evaluation or with the use of typical ancillary medical 
treatments or care used before, during, or after treatments 
• 
Received or is anticipated to receive antiplatelets, anticoagulants, 
thrombolytics, vitamin E, or anti-inflammatories within 2 weeks prior to 
treatment 
• 
Intolerance or allergy to medications that could be prescribed before or after 
the procedure (eg, antibiotics, anesthesia) 
• 
A history of keloids 
• 
A history or evidence of poor wound healing 
• 
A history of coagulative disorder or current use of anticoagulant drugs within 
2 weeks of study participation 
• 
Use of steroids within 2 weeks of study treatments 
• 
Patients with implanted pacemaker or defibrillator, or metal pins, or prosthetic 
joints within 4 cm of treatment area 
• 
History of psychoneurosis and/or a history of alcohol or drug abuse 
Primary Endpoint: 
• 
Group A: Evaluation of randomized before treatment and 3-month follow-up 
images by blinded evaluators  
• 
Group B: Complete wound healing following the treatment assessed by 
collected biopsies. 
Secondary Endpoints: 
• 
Adverse Event Assessment 
• 
Subject satisfaction  
• 
Physician satisfaction 
• 
Subject Clinical Global Aesthetic Improvement Scale 
• 
Physician Clinical Global Aesthetic Improvement Scale 
• 
Histological Evaluation 
Safety Variables: 
• 
Prior to treatment, the participant’s medical history will be reviewed, pregnancy 
history will be documented, and a physical examination will be conducted.  
• 
At each subsequent visit, the participant will be queried about adverse events and 
changes in concomitant medications, and the treatment area will be visually 
examined. 
Study Duration: 
The duration from when the study opens to enrollment until completion of data 
analyses is anticipated to be 18 months. 
 
 
 
 
 
 
 

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Table of Contents 
Sponsor Statement and Signature Page .................................................................................... 2 
Sponsor Contact Information .................................................................................................... 4 
Statement of Compliance ......................................................................................................... 5 
List of Abbreviations ................................................................................................................. 6 
Protocol Synopsis ..................................................................................................................... 7 
List of Figures and Tables ....................................................................................................... 12 
1. 
KEY ROLES ..................................................................................................................... 13 
1.1 
Internal Responsibilities......................................................................................................... 13 
2. 
INTRODUCTION ............................................................................................................. 13 
2.1 
Background Information ........................................................................................................ 13 
2.1.1 
Device Name and Indications for Use ..................................................................................................... 13 
2.1.2 
Brief Skin Condition Background and Treatment Overview .................................................................... 13 
2.1.3 
Mechanism of Actions ............................................................................................................................. 14 
2.1.4 
Device Overview ...................................................................................................................................... 14 
2.2 
Rationale ............................................................................................................................... 17 
2.3 
Potential Risks and Benefits ................................................................................................... 17 
2.3.1 
Known Potential Risks ............................................................................................................................. 17 
2.3.2 
Known Potential Benefits ........................................................................................................................ 18 
3. 
OBJECTIVES AND PURPOSE ............................................................................................ 18 
4. 
STUDY DESIGN AND AIM ............................................................................................... 18 
4.1 
Description of the Study Design ............................................................................................. 18 
4.2 
Duration of Study .................................................................................................................. 19 
4.3 
Study Endpoints .................................................................................................................... 19 
4.3.1 Primary Endpoint............................................................................................................................................ 19 
4.3.2 Secondary Endpoints ...................................................................................................................................... 19 
5. 
PARTICIPANT ENROLLMENT AND WITHDRAWAL ........................................................... 20 
5.1 
Participant Enrollment ........................................................................................................... 20 
5.1.1  
Informed Consent .................................................................................................................................... 20 
5.1.2  
Pre-treatment Recruiting/Screening ....................................................................................................... 20 
5.2 
Participant Inclusion Criteria .................................................................................................. 20 

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5.3 
Participant Exclusion Criteria ................................................................................................. 21 
5.3 
Strategies for Recruitment and Retention .............................................................................. 21 
5.3.1 
Participant Payment ................................................................................................................................ 22 
5.4  
Participant Withdrawal or Termination .................................................................................. 22 
5.5 
Premature Termination or Suspension of the Study or a Study Site ......................................... 22 
6. 
STUDY PROCEDURES AND SCHEDULE............................................................................. 23 
6.1 
Study Images ......................................................................................................................... 23 
6.2 
Study Schedule ...................................................................................................................... 23 
6.2.1 
Unscheduled Visit .................................................................................................................................... 24 
6.3 
Study Treatment .................................................................................................................... 24 
6.3.1 
Pre-Treatment Medications .................................................................................................................... 24 
6.3.2  
Participant Preparation for Study Treatment .......................................................................................... 24 
6.3.3 
Study Treatment ...................................................................................................................................... 24 
6.3.4 
Acute Responses ..................................................................................................................................... 25 
6.3.5 
Post-Treatment Care ............................................................................................................................... 25 
6.3.6  
Elective Skin Biopsy ................................................................................................................................. 25 
6.4  
Follow-Up Visits ..................................................................................................................... 26 
6.5 
Concomitant Medications ...................................................................................................... 26 
7. 
ASSESSMENT OF SAFETY ............................................................................................... 26 
7.1 
Specifications of Safety Parameters ....................................................................................... 26 
7.1.1 
Definition of an Expected Treatment Effect (ETE) and an Adverse Event (AE) ....................................... 27 
7.1.2 
Definition of Serious Adverse Event (SAE)............................................................................................... 27 
7.1.3 
Definition of Unanticipated Adverse Device Effects (Events) ................................................................. 27 
7.2 
Classification of an Event ....................................................................................................... 27 
7.2.1 
Severity of Event...................................................................................................................................... 27 
7.2.2 
Relationship to the Investigational Device .............................................................................................. 28 
7.2.3 
Expectedness ........................................................................................................................................... 28 
7.3 
Time Period and Frequency for Event Assessment and Follow-up ........................................... 28 
7.4 
Reporting Procedures ............................................................................................................ 29 
7.4.1 
Adverse Event Reporting ......................................................................................................................... 29 
7.4.2 
Serious Adverse Event Reporting ............................................................................................................ 29 
7.4.3 
Unanticipated Adverse Device Effect Reporting ..................................................................................... 29 
7.4.4 
Reporting of Pregnancy ........................................................................................................................... 29 
7.4.5 
Reporting of Deaths ................................................................................................................................ 30 
8. 
CLINICAL MONITORING ................................................................................................. 30 
9. 
STATISTICAL ANALYSIS .................................................................................................. 31 

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9.1 
STATISTICAL AND ANALYTICAL PLANS .................................................................................... 31 
9.2 
ANALYSIS DATASETS .............................................................................................................. 31 
10. 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA / DOCUMENTS ............................ 32 
11. ETHICS/PROTECTION OF HUMAN PARTICIPANTS ............................................................... 32 
11.1 
Ethical Standard ................................................................................................................. 32 
11.2 
Institutional Review Board ................................................................................................. 32 
11.3 
Informed Consent Process .................................................................................................. 33 
11.3.1 
Consent/Assent and Other Informational Documents Provided to Participants .................................... 33 
11.3.2 
Consent Procedures and Documentation ............................................................................................... 33 
11.4 
Participant and Data Confidentiality ................................................................................... 33 
12. 
DATA HANDLING AND RECORD KEEPING ....................................................................... 34 
12.1 
Data Collection and Management Responsibilities .............................................................. 34 
12.2 
Investigator Records and Reports ....................................................................................... 34 
12.2.1 
Investigator Records ................................................................................................................................ 34 
12.2.2 
Investigator Reports ................................................................................................................................ 35 
12.3 
Study Records Retention .................................................................................................... 35 
12.4 
Protocol Deviations ............................................................................................................ 36 
12.5 
Publication and Data Sharing Policy .................................................................................... 36 
13. 
STUDY ADMINISTRATION .............................................................................................. 36 
13.1 
 Study Investigators ............................................................................................................ 36 
13.2 
Amendment Policy ............................................................................................................. 36 
14. 
CONFLICT OF INTEREST POLICY ...................................................................................... 37 
APPENDIX A: Device Operator Manual ............................................................................................. 38 
Appendix B: Mosaic Ultra Treatment Guidelines ............................................................................... 39 
PROTOCOL REVISIONS  LOG .................................................................................................... 40 
  
 
 

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LIST OF FIGURES AND TABLES 
Table 1: Internal Responsibilities. .................................................................................................................................... 12 
Figure 1: Mosaic Ultra Laser System Components. ................................................................................................... 14-15 
Table 2:  Device Specifications......................................................................................................................................... 15 
Table 3: Satisfaction Scale  . ............................................................................................................................................ 18 
Table 4: Clinical Global Aesthetic Improvement Scale..................................................................................................... 18 
Table 5: Study Schedule. .................................................................................................................................................. 22 
Table 6: Relationship Between Adverse Events and Investigational Device. ................................................................... 25 
 

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1. 
KEY ROLES 
Persons serving in key roles in the conduct or oversight of this clinical trial are listed in Table 1.1-1 below.  
 
1.1 
INTERNAL RESPONSIBILITIES 
TABLE 1: INTERNAL RESPONSIBILITIES 
Name 
Function 
Address 
Lutronic Global 
Sponsor 
19 Fortune Drive 
Billerica, MA 01821 
Phone: 888.588.7644 
Paul Cardarelli 
Exec. Director, Clinical Research 
Phone: 801.244.0058 
Email: pcardarelli@lutronic.com 
2. 
INTRODUCTION 
2.1 
BACKGROUND INFORMATION 
2.1.1 DEVICE NAME AND INDICATIONS FOR USE 
The Mosaic Ultra is an investigational device for dermatological treatments and skin regeneration procedures that 
require coagulation of soft tissues. The system emits 1550nm laser light at various pulse durations/configurations 
via optical fiber through a handpiece.  
 
The Mosaic Ultra laser system is a 1550nm Er:Glass laser which delivers energy through an optical fiber system.  The 
device is capable of using three different tips which are the roller tip, static tip (which comes in a circle, rectangle, 
and square format, as well as a comb tip.  Laser energy is delivered when the device is activated via a foot switch.  
Patient comfort is managed using air cooling.   
 
The clinical trial described in this protocol evaluates clinical outcomes associated with the treatment of various 
indications.  The primary method of evaluation will be the assessment of before and after photography by blinded 
evaluators.  Treated areas and results will be evaluated by both the physician and the subject for both satisfaction 
and CGAIS. 
 
2.1.2 BRIEF SKIN CONDITION BACKGROUND AND TREATMENT OVERVIEW 
The Mosaic Ultra can potentially treat skin tone and texture, facial rejuvenation, photoaging, wrinkles, scars, stetch 
marks, acne vulgaris and hair loss. 
 
Pigmented lesions refer to a wide range of abnormalities that can be found on the skin, including not limited to 
lentigos (age spots), solar lentigos (sunspots), and ephelides (freckles). Many people develop brown lesions on their 
skin from chronic sun exposure, time, and other factors. These can appear on the face, hands, upper chest, and other 
locations and tend to make the skin look prematurely aged. 
Uneven skin tone and skin texture can occur naturally over time as the skin is exposed to UV rays from the sun.  This 
exposure causes the skin to produce melanin which results in the skin having dark spots resulting in the uneven tone.  

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This same exposure can cause a breakdown of the skin’s natural collagen and elastin which typically support healthy 
skin.  As the collagen and elastin breaks down it can cause the skin to dry out and become rougher resulting in an 
undesired skin texture.   
Wrinkling occurs due to a variety of factors but results in the skin folding into itself and instead of appearing smooth 
the skin has folds, ridges, and creases.  Wrinkles can occur as part of the natural ageing process, exposure to the sun, 
and a large variety of lifestyle and health habits. 
Scars are marks on the skin that are left after the body heals from a wound and are typically a sign that the skin did 
not heal uniformly.  Scars can occur due to a variety of wounds such as (but not limited to) acne inflammation, 
accidental injuries and cut and burns. 
Stretch marks, also known as striae, occur when the skin has been rapidly stretched.  The most common cause of 
stretch marks are pregnancy, but they can also occur if a person gains or loses weight in a short period of time.  
Stretch marks are typically smaller indented streaks and lines on the skin that can come in many colors such as pink, 
red, black, blue or purple.   
Acne vulgaris is a very common skin issue that is a result of hair follicles under the skin becoming plugged or clogged.  
It results in small red bumps on the skin which can be painful to some patients due to the inflammation of the hair 
follicles.   
Hair loss and hair thinning is a common issue where the hair stops naturally growing in certain spots and is typically 
only a concern when this occurs on the head.  There are a variety of reasons this can occur but the general idea to 
treat this issue is by promoting cell proliferation, increasing overall cell survival and promoting the anagen phase of 
the hair follicles. 
There are a variety of treatment options such as topical therapies (tretinoin or topical vitamin C), cryotherapy, and 
various lasers and energy delivery devices that have been developed to improve skin tone and texture, facial 
rejuvenation, photoaging, wrinkles, scars, stretch marks, acne vulgaris and hair loss. 
 
 
2.1.3 Mechanism of Actions 
The Mosaic Ultra is designed for specific clinical indications and emits 1550nm light. The light energy is directed to 
the treatment zone through an optical fiber coupled with a handpiece. 
 
Laser use in dermatology relies on the basis that certain targets for energy absorption (chromophores) are capable 
of absorbing energy from specific wavelengths (absorptive band) without exclusively being targeted by their highest 
absorption peak. The working basis for this concept rests on the principles of selective photothermolysis, in which 
thermally mediated radiation damage is confined to chosen epidermal and/or dermal structures at the cellular or 
tissue structural levels. Tissues surrounding these targeted structures, including overlying or immediately 
neighboring cells, are spared, potentially reducing nonspecific, widespread thermal injury. The three main 
chromophores (hemoglobin, water, and melanin) in human skin all have broad absorption peaks of light energy, 
allowing them to be targeted using both broad and specific wavelengths of light. 
 
2.1.4 Device Overview 
The Mosaic Ultra laser system consists of the following components: 

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• 
Main system body 
• 
Laser Delivery System (optical fiber with installed handpiece) 
• 
Foot switch 
FIGURE 1: MOSAIC ULTRA LASER SYSTEM COMPONENTS 
 

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TABLE 2: DEVICE SPECIFICATIONS 
Items 
System Specificaionts 
Laser wavelength 
1550nm 
Laser medium 
Er:Glass 
Laser delivery system 
Optical fiber with handpiece installed 
Laser aiming beam 
658nm, < 5mW 
Pulse energy 
4 ~ 120mJ 
Pulse rate 
115.4 ~ 447.4Hz 
Pulse duration 
0.235 ~ 6.667ms 
Device Class 
CDRH Class 
Class IV 
MDR Class 
Class IIb 
Applied Part Class 
B 
FDA Class 
Class II 
Radiation Area 
(mm x mm) 
Roller Tip 
15x1 
Static Tip 
Circle (Diameter) 
2, 4, 6, 8, 10, 12 
Rectangle 
3x10, 5x10, 6x12, 8x12, 
8x16, 8x20 
Square 
2x2, 4x4, 6x6, 8x8, 10x10, 
12x12, 
16x16, 
18x18, 
20x20 
Comb Tip 
12x2 
Laser radiation control 
 
Foot switch 
Display system 
10.1" Touch LCD Display 

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Cooling system 
Air cooling 
IP rate 
Main body: IPX0  
Foot switch: IP68 
Electrical specifications 
AC100~240, 50Hz/60Hz (Fuse AC250V/6.3A) Max Power: 350VA 
 
2.2 
RATIONALE 
In accordance with the definition of “Significant Risk Device” provided in 21 CFR 812.3, the device to be used in this 
study has been determined to be a Non-Significant Risk device based on the following: 
a) It is not an implant. 
b) It is not purported or represented to be for use in supporting or sustaining human life and do not 
present a potential for serious risk to the health, safety, or welfare of a participant. 
c) It is not for a use of substantial importance in diagnosing, curing, mitigating, or treating disease or 
otherwise preventing impairment of human health. 
d) Use of the device does not pose a serious risk to the health, safety, or welfare of a participant. 
 
The current clinical plan is expected to evaluate the safety and effectiveness of the Mosaic Ultra laser system.  
2.3 
POTENTIAL RISKS AND BENEFITS 
2.3.1 KNOWN POTENTIAL RISKS 
This treatment modality was designed to inherently minimize the risk to the participant. As with any laser device 
treatment, there is a risk of adverse events, skin reactions or side effects. Expected side effects include:  
• 
Discomfort: When a pulse is triggered, it may cause various degrees of discomfort. Some describe the 
sensation as stinging. A burning sensation may last for up to an hour after treatment.  
• 
Blistering and burns  
• 
Discoloration: Every laser treatment carries the possibility of permanent skin discoloration. Post-
inflammatory hyperpigmentation and pigmentation are widely known complications of laser treatment.  
• 
Eye injury: Protective glasses or goggles are provided for operators and assistants. It is extremely 
important to wear eye protection at all times during treatment to protect the eyes from accidental 
exposure to laser and serious injury.  
• 
Infection: Every scar left on the skin carries the risk of infection. This risk of infection may also be 
associated with machines such as the MOSAIC ULTRA laser system. If detected, any infection should 
properly be treated with topical and/or systemic medications.  
• 
Keloid formation: Scars may become thickened due to excessive growth of fibrous tissue.  
• 
Prolonged redness: A mild case of temporary red spots is an expected reaction. However, if the red spots 
appear severe or last much longer than expected, do not repeat the treatment until the spots have 
disappeared. This reaction may vary by patient.  

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• 
Scarring: There is a possibility that scars may form due to treatment with the MOSAIC ULTRA laser system. 
Scars may form locally if treatment procedures are not properly followed, which may lead to exposure to 
laser, infection or physical irritation of the area such as wiping or rubbing.  
• 
Delayed wound healing/skin textural changes: After laser treatment, the reepithelialization process may 
not proceed as expected due to the patient’s physiological characteristics (e.g. lack of wound healing 
ability or poor care after treatment). This may result in undesirable changes to the skin texture.  
• 
Temporary bruising  
 
2.3.1.1  MINIMIZATION OF POTENTIAL RISKS 
The risks listed above are minimized by treating a small area of the skin and noting the participant’s sensation and 
inflammatory response. Potential risks will be further minimized or reduced by monitoring the participant during 
the treatment/exposure and observing the skin’s response to receiving the treatment/exposure. If the 
treatment/exposure is not tolerated, the investigator (or delegated clinician) must stop administering the exposure 
for the participant’s safety, and the participant will be followed for adverse events for through resolution of the 
adverse event and/or 30 days.  
2.3.1.2 SAFETY VARIABLES 
Prior to the first exposure, the participant’s medical history will be reviewed, pregnancy history will be documented, 
and a physical examination of the treatment area will be conducted to ensure it is free of open wounds. At each 
subsequent visit, the participant will be queried about adverse events and changes in concomitant medications, and 
the exposure area will be visually examined.  
 
2.3.2 KNOWN POTENTIAL BENEFITS 
There is a potential benefit to participants of this study who are seeking improved appearance of pigmented lesions 
and vascular lesions of the face. Results of the study may contribute to further the development of the Lutronic 
Mosaic Ultra laser system.  
3. 
OBJECTIVES AND PURPOSE 
The objective of this study is evaluate the safety and effectiveness of the Mosaic Ultra laser system for the treatment 
of cutaneous lesions, periorbital wrinkles, acne scars, and surgical scars. 
For subjects in group B, the primary objective will be evaluation of the histological changes via post-treatment 
biopsies to confirm appropriate wound healing post treatment 
4. 
STUDY DESIGN AND AIM 
4.1 
DESCRIPTION OF THE STUDY DESIGN 
This study is a prospective clinical trial to be conducted at three clinical sites. Up to 210 participants will be enrolled 
and receive study treatment (total enrollment may be more than 210, due to screen failures) if they meet the 
inclusion/exclusion criteria and provide written informed consent.  The study will be used to confirm parameters 

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and safety across a wide variety of clinical indications.  Group A may have up to 180 subjects enrolled into the 
treatment arm, Group B may have up to 30 patients enrolled into the biopsy arm.  
4.2 
DURATION OF STUDY 
The duration from when the study opens to enrollment until completion of data analysis is anticipated to be 18 
months. 
4.3 
STUDY ENDPOINTS 
4.3.1 PRIMARY ENDPOINT  
The primary endpoint of this study is:   
1. Group A: Selection of post-treatment images when randomized with baseline images as assessed by blinded 
evaluators 
2. Group B: Evaluation of histological samples taken via punch biopsies to observe treatment effect and wound 
healing. 
 
4.3.2 SECONDARY ENDPOINTS 
The secondary endpoints of this clinical trial include:  
1. Subject satisfaction  
2. Physician satisfaction 
Table 3:  Satisfaction Scale 
Score 
Rating 
6 
Extremely Satisfied 
5 
Satisfied 
4 
Slightly Satisfied 
3 
Slightly Dissatisfied 
2 
Dissatisfied 
1 
Extremely Dissatisfied 
 
3. Physician CGAIS 
4. Subject CGAIS 
Table 4:  Clinical Global Aesthetic Improvement Scale1 
Score 
Rating 
Description 
5 
Very Much Improved 
Optimal cosmetic result in the subject 
4 
Much Improved 
Marked improvement in appearance from the initial condition, but not 
completely optimal 
3 
Improved 
Obvious improvement in appearance from initial condition, but further 
treatments may be beneficial 
2 
No Change 
The appearance is essentially the same as the original condition 
1 
Worsened 
The appearance is worse than the original condition 
 
5. Adverse event assessment 
 

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4.4 
SUCCESS CRITERIA 
The study will be considered a success if the following criteria are met: 
Group A: Clinical Treatment Arm 
1. Blinded evaluators are able to correctly identify the post-treatment image at least 80% of the time 
2. The adverse event and side effect profile are acceptable 
 
Group B: Biopsy Arm 
1. Wounds induced by the treatment device appropriately healed as assessed by histology. 
5. 
PARTICIPANT ENROLLMENT AND WITHDRAWAL 
5.1 
PARTICIPANT ENROLLMENT 
The study population will consist of male and female patients between 20 and 60 years old who have chosen to 
participate in this clinical trial as evidenced by execution of the informed consent document. 
 
5.1.1  INFORMED CONSENT 
Investigators have ethical and legal responsibilities to ensure that the protocol is clearly explained to each participant 
considered for enrollment in the study. Compliance with this requirement should be documented on a written 
Informed Consent Form approved by the reviewing IRB. Each Informed Consent Form will include the elements 
required by FDA regulations in 21 CFR Part 50. 
The IRB-approved Informed Consent Form will be signed by the study personnel obtaining consent. The participant 
will be given a copy of the signed Informed Consent Form. The investigative site will keep the original on file. 
Written informed consent will be obtained from all participants (and/or parents, guardians, legal representatives) 
before any study-related procedures, including any pre-treatment screening procedures, are performed. 
Investigators, or delegated study personnel, may discuss the availability of the study and the possibility for entry 
with a potential participant without first obtaining consent. Informed consent must be obtained and documented 
prior to initiation of any procedures that are performed solely for the purpose of determining eligibility for research. 
 
5.1.2  PRE-TREATMENT RECRUITING/SCREENING 
Participants will be recruited from the study site’s patient database or IRB-approved advertisement and then 
subsequently screened. Study site personnel will explain the design and purpose of the study to potential study 
participants. Participants interested in participating will visit the study site where informed consent will be obtained.   
5.1.2.1 SCREEN FAILURES 
A screening failure participant is one from whom informed consent is obtained and is documented in writing (ie, 
participant signs an Informed Consent Form), but who does not receive a test spot exposure visit because of failure 
to meet all of the eligibility criteria. Screening failure participants will be included in the total number of participants 
enrolled (ie, all participants consented), but not counted towards the total participants treated. 
5.2 
PARTICIPANT INCLUSION CRITERIA 
Participants must meet all of the following criteria for study enrollment: 

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• 
Non-smoking, Male or Female 
• 
Age 20 – 60 years old  
• 
Understands and accepts the obligation not to undergo any other procedures in the areas to be treated. 
• 
Participants who are willing and able to comply with all study participation requirements including returning 
for follow-up visits and abstaining from exclusionary procedures for the duration of the study. 
• 
Participants who are willing to undergo biopsies. 
5.3 
PARTICIPANT EXCLUSION CRITERIA 
Participants will be excluded if they meet any of the following criteria: 
* 
Previous surgical or cosmetic procedure to the target area in the last 6 to 12 months that could interfere 
with the treatment procedure 
* 
A study participant must not be pregnant or have been pregnant in the last 3 months  
* 
A recent history of smoking (6 months)  
* 
Presence of an active skin disease or condition that may affect wound healing (ie. diabetes myelitis; 
connective tissue disease; radiation therapy; or chemotherapy) 
* 
Seizure disorder caused by bright light 
* 
A history of thrombophlebitis 
* 
A history of acute infections 
* 
A history of heart failure 
* 
Cancer, malignant disease, skin pathology, condition, or allergic reactions that could interfere with 
evaluation or with the use of typical ancillary medical treatments or care used before, during, or after 
treatments 
* 
Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E, or anti-
inflammatories within 2 weeks prior to treatment 
* 
Intolerance or allergy to medications that could be prescribed before or after the procedure (eg, 
antibiotics, anesthesia) 
* 
A history of keloids 
* 
A history or evidence of poor wound healing 
* 
A history of coagulative disorder or current use of anticoagulant drugs within 2 weeks of study 
participation 
* 
Use of steroids within 2 weeks of study treatments 
* 
Patients with implanted pacemaker or defibrillator, or metal pins, or prosthetic joints within 4 cm of 
treatment area 
* 
History of psychoneurosis and/or a history of alcohol or drug abuse 
After participants have provided informed consent and met the inclusion/exclusion criteria, the study procedures 
described in the following section will be performed.  
5.3 
STRATEGIES FOR RECRUITMENT AND RETENTION 
Participants will be recruited from the site’s patient database. The next appointment should be scheduled prior to 
the participant leaving the current appointment. 
 
All participants who have signed an Informed Consent Form, except for screen failures, will be considered enrolled 
in the study. Participants who complete the study duration will be considered to have completed the study. Any 
participant who does not return for a scheduled follow-up visit will be contacted at least twice by telephone to 

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determine the cause for the missed visit and to try to get the participant scheduled for the follow-up. A new visit will 
be scheduled as soon as possible. All participants should be followed until completing the study follow-up or until 
study discontinuation (withdrawal) for other reasons. The reason for study discontinuation should be documented 
for each participant. Participants will be deemed “Lost-to-Follow-up” if they have not returned within six weeks after 
the last follow-up target. For any participant deemed lost-to-follow-up, at least three attempts to contact the 
participant must be documented (the attempts must be two phone calls/emails and a registered letter). 
 
5.3.1 PARTICIPANT PAYMENT 
Participant visits where treatments are delivered will not be compensated. Screening/Baseline visit will not be 
compensated.  Participants in Group A, the clinical treatment arm, will be compensated $50 for attending the 30- 
and 90-day follow-up visits.  Participants who are selected and choose to participate in the elective skin biopsy of 
Group A or who are enrolled in Group B, the biopsy arm, will receive $100 per biopsy. 
5.4  
PARTICIPANT WITHDRAWAL OR TERMINATION 
All participants have the right to withdraw at any point during the study without prejudice. The investigator can 
discontinue any participant, at any time, if medically necessary. Participants must be discontinued from the 
investigation by the investigator at any time for any of the following reasons: 
• 
Withdrawal of informed consent. 
• 
Pregnancy (no further study-related treatments will be performed; however, the follow-up visit will be 
completed if the study treatments has been completed and the participant will be followed to term, 
called after the pregnancy, child birth, and/or pregnancy termination, and queried for abnormalities or 
complications). 
• 
Any AEs for which treatment continuation would constitute an unacceptably high-risk for the participant. 
 
The reason for any participant’s withdrawal should be documented on the appropriate study-specific data form. 
5.5 
PREMATURE TERMINATION OR SUSPENSION OF THE STUDY OR A STUDY SITE 
The study or a study site can be prematurely terminated or suspended by the sponsor. Reasons for termination of 
the study or a study site may include, but are not limited to, the following: 
• 
Participant enrollment is unsatisfactory. 
• 
The risks and benefits of continuing the study have been reassessed, and the risks outweigh any potential 
benefits. 
• 
The incidence of AEs constitutes a potential health hazard to the participants. 
• 
New scientific data do not justify a continuation of the study. 
• 
The investigator or study site exhibit serious and/or persistent non-adherence to the protocol, the 
Declaration of Helsinki, EN ISO 14155, and/or applicable regulatory requirements. 
• 
The sponsor decides to terminate the study at any time for any other reason. 
Furthermore, the study may be prematurely ended if the regulatory authority or the IRB has decided to terminate 
or suspend approval for the study, the study site, or the investigator. 
If the study is prematurely terminated or suspended for any reason, the investigator must inform the participants 
and assure appropriate follow-up treatment. Within the timeframes noted in applicable regulations, the sponsor will 
promptly inform the investigators, study sites, the IRB, and regulatory authorities of the termination or suspension 
of the study, as well as provide reasons for the action. 

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6. 
STUDY PROCEDURES AND SCHEDULE 
6.1 
STUDY IMAGES 
Standardized baseline and follow-up images will be taken. All participant photos must be taken in a standardized 
format. Review each item on the checklist below every time study photos are taken to ensure “Standardized Images” 
are taken.  
PRIOR TO TAKING PHOTOGRAPHS: 
 
Natural Skin; skin washed, and no make-up 
 
Jewelry removed 
 
For any body part being treated, ensure a black background is in place 
 
Treatment area may be marked with a surgical marker prior to photographs 
 
WHILE TAKING PHOTOGRAPHS: 
 
Ensure photograph is in focus 
 
For facial images, take five images: front, left 45 o, left 90 o, right 45 o, right 90o 
 
For all other body parts, take one to three images to adequately capture the participant 
 
AFTER TAKING PHOTOGRAPHS (before participant  leaves the office): 
 
Ensure all views have been taken 
 
Ensure all photographs are in focus 
 
Ensure lighting is consistent 
 
Ensure all follow-up photographs are similar to baseline images in views, angles, lighting, placement, and 
distance. 
6.2 
STUDY SCHEDULE 
Table 5:  Study Schedule 
Group A – Clinical Treatment Arm – Schedule and Planned Activities 
 
Screening 
 
Treatment 
 
Post 
Treatment 
Follow-Up 
(optional) 
1-7days post Tx 
Follow-Up 
30-day post 
final TX 
Follow-Up 
90-day post 
final TX 
Visit Number 
1 
2, 4, 6, 8, 10 
3, 5, 7, 9, 11 
12 
13 
Study Day # 
0 
0 – 140 
1-147 
170 (±7) 
230 (±14) 
Screening Activities 
X 
 
 
 
 
Pregnancy Test 
X 
X 
 
 
 
Photographs 
 
X 
X 
X 
X 
Device Treatment 
 
X 
 
 
 
Biopsy (optional) 
 
X 
X 
X 
X 
Adverse Event Assessment 
 
X 
X 
X 
X 
Subject Evaluations 
 
 
 
X 
X 
Physician Evaluation 
 
 
 
X 
X 
 

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Group B – Biopsy Arm – Schedule and Planned Activities 
 
Screening 
(Visit 1) 
Treatment 
(Visit 2) 
Follow-Up 
Phone Call 
Follow-Up 
Biopsy  
Follow-Up 
Biopsy 
Visit Number 
1 
2 
3 
4, 5 
6 
Study Day # 
0 
0 
2 (±1) 
4 (±1), 12 (±2) 
19 - 90 
Screening Activities 
X 
 
 
 
 
Pregnancy Test 
X 
X 
 
 
 
Photographs 
 
X 
 
X 
X 
Biopsy 
 
X 
X 
X 
X 
Adverse Event Assessment 
 
X 
X 
X 
X 
 
6.2.1 UNSCHEDULED VISIT 
Any unscheduled visit or examination should be documented in the participant’s medical record and adverse event 
form (if applicable) stating the reason for the visit and any actions taken. The Sponsor should be notified of the 
unscheduled visit. 
6.3 
STUDY TREATMENT 
Participants in Group A, the clinical treatment arm, will receive up to 5 treatments at the investigator’s discretion 
using the Mosaic Ultra Treatment Parameter Guidelines as a starting point for the treatment parameters.  
Treatments will occur 2-6 weeks apart depending on the clinical indication being treated.  Participants in Group B, 
the biopsy arm, will only receive one treatment with pre-determined parameters in a discrete area of the body (such 
as abdomen, buttocks, back). 
 
6.3.1 PRE-TREATMENT MEDICATIONS 
No pre-treatment medication prior to study treatment.  
 
6.3.2  PARTICIPANT PREPARATION FOR STUDY TREATMENT 
The investigator, sub-investigator, or delegated clinician will first identify the skin areas to which 
treatment/exposure is to be performed. Treatment records will be maintained in accordance with this protocol. Skin 
in treatment area should be cleansed with mild cleaner. No lotion, make-up, perfume, powder, or oil should be 
present on the area to be treated. Area will be fully cleansed prior to treatment. Test spots will be done as per the 
Mosaic Ultra guidelines to ensure the device settings are appropriate for the skin type (with adjustments to be made 
to the device settings as determined appropriate from observation of the reaction of the test spots). 
 
6.3.3 STUDY TREATMENT 
All study treatments will be performed by the investigator, sub-investigator, or delegated clinician (ie, study 
exposure clinician as designated by the principal investigator).  Participants will receive up to 5 treatments at the 
investigator’s discretion using the Mosaic Ultra Treatment Parameter Guidelines as a starting point for the treatment 
parameters.  The participants will be monitored during the exposure. The participant’s pain levels will be monitored 
using a standard pain scale assessment (0-10). The average pain score will be recorded.  Participants in Group B, the 
biopsy arm, will receive treatment in a discrete area such as the back, abdomen, or buttocks.   

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6.3.4 ACUTE RESPONSES 
For all exposures, acute responses (eg, erythema or edema) will be observed by the study exposure clinician and 
recorded after exposure. If any Serious Adverse Events (SAE) are noted, an SAE Form should be completed. 
 
6.3.5 POST-TREATMENT CARE 
Participants will be advised: 
• 
Do not use any scrubbing product for one week after treatment. 
• 
Do not use functional cosmetics (eg, retinol, AHA) for 2 days. 
• 
Avoid saunas for at least one week. 
• 
Do not use cosmetic products (toner, lotion) containing alcohol. They may cause skin irritation. Use a mild 
moisturizer. 
• 
Apply sun block cream (SPF 30, PA++) everyday, to prevent PIH. It is advisable to wear a hat and take an 
umbrella when going outside for 30 days after the procedure. 
• 
Skin Dryness are normal reactions associated with the thermal effect, so please apply moisturizing cream 
frequently. 
For subjects in Group B, post-biopsy instruction will be provided to the participant.  The participant will be 
instructed to not fully submerge the biopsy site in water.  The bandage or coverings for the biopsy site should be 
changed on a daily basis and should also be changed if it becomes wet or damp.  The subject will also be told that 
once a scab or new skin begins to grow over the area and that the bleeding from the biopsy site has stopped they 
can discontinue the wound treatment regimen and remove the bandage.  
Other post-treatment procedures will be considered and used as deemed by a clinician to be standard and 
reasonable care. Participants will be instructed that blistering, bleeding, oozing, strong pain, excessive swelling 
persisting for more than 48 hours, or signs of infection (eg, itching; pus; drainage; fever; chills) are cause for 
immediate concern.  
There is a risk of an allergic reaction to the anesthetic or oral medication used in treatment and/or the biopsy. An 
allergic reaction to the anesthetic may cause: hives, itching, swelling, faintness, low blood pressure, difficulty 
breathing, and life-threatening shock. In the event of the aforementioned infection or allergic reaction scenarios, 
immediate emergencies (medically unstable) must be triaged in emergency care.  
If the aforementioned side-effects are not an immediate emergency (medically stable), participants should contact 
the investigator and/or his designee, to be evaluated and potentially treated at no cost to the participant. An 
unscheduled visit will be arranged so that the Investigator can clinically evaluate and photograph these findings. 
 
6.3.6  ELECTIVE SKIN BIOPSY 
Some study-site locations may offer an elective skin biopsy for histological evaluations. The biopsy is considered a 
safe, low-risk procedure. 
 
The biopsy procedure will involve collecting a small sample of skin from the participant in a discreet location. The 
punch biopsy, a tool that is usually circular at the extraction site, removes a small, round sample of the epidermis, 
dermis, and superficial fat (while leaving the extracted layers intact). 

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Prior to biopsy, participant skin will be cleaned and dried by the treating clinician. The punch instrument is pressed 
vertically into the skin and then rotated clockwise and counterclockwise between the fingertips. A small “give” can 
be felt as the device cuts through the epidermis and dermis, down to the superficial layer of subcutaneous fat. 
The punch biopsy tool is designed to collect tissue very quickly (to reduce pain) and is also designed to reduce the 
risks of bleeding through precision. However, some temporary pain and minor bleeding can occur at the biopsy site.  
The biopsy site will be covered with a bandage. There is a small risk of infection and participants must commit to 
taking care of biopsy site. Participants will be advised to regularly clean the biopsy site with mild soap and water, 
and to keep it bandaged (a simple bandaid is often enough) until it is fully healed (approximately one month). 
 
For patients participating in the Group B of the study, the intended treatment area of the subject will be marked and 
photographed prior to treatment and a control biopsy will be taken.  The first biopsy (Day 0, control) will be collected 
at this time.  A normal treatment will be then be conducted using pre-determined laser parameters.  Subject will 
then have a biopsy taken immediately post treatment from the treated area. 
 
6.4  
FOLLOW-UP VISITS 
Post-treatment follow-ups may occur up to 7 days post-treatment.  These follow-ups are optional and may be 
conducted in-phone, over email, or in-person as determined by the clinician.  If an optional post-treatment follow-
up is determined necessary by the clinician the subject will be notified before the end of their treatment visit and 
the visit will be scheduled at that time.  Adverse events will be evaluated at this visit.  If subject has elected to 
participate in the biopsy portion of the study then a biopsy may also be collected at this visit. 
 
In-person follow up visits will occur 30±7 and 90±14 days post final treatment.  Adverse events will be assessed at 
these visits.  Subjects will be asked to rate their satisfaction (Table 3) with their overall results as well as grade their 
improvement on the CGAIS (Table 4).    
 
Subjects in Group B will then return 3 and 14 days  post treatment to have an additional biopsy collected from the 
treated area.  Subject’s will then return for a final follow-up for biopsy collection between 19 and 90 days post 
treatment.  Photos will be taken at all visits to ensure proper collection of biopsies as well as to capture the skin 
response. 
 
6.5 
CONCOMITANT MEDICATIONS 
All concomitant prescription medications taken during study participation will be recorded on the appropriate study-
specific data form. For this protocol, a prescription medication is defined as a medication that can be prescribed only by 
a properly authorized/licensed clinician. Medications to be reported on the data form and entered on the CRF are 
concomitant prescription medications, over-the-counter medications, and non-prescription medications. 
7. 
ASSESSMENT OF SAFETY 
7.1 
SPECIFICATIONS OF SAFETY PARAMETERS 
 

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7.1.1 DEFINITION OF AN EXPECTED TREATMENT EFFECT (ETE) AND AN ADVERSE EVENT (AE) 
An expected treatment effect is defined as any typical treatment side-effect of the study devices of mild to moderate 
severity and lasting up to a typical maximum duration. An adverse event is defined as any new medical problem, or 
exacerbation of an existing problem, experienced by a participant while enrolled in the study, whether or not it is 
considered device-related by the investigator. All ETEs and AEs will be collected during the conduct of this trial. 
 
7.1.2 DEFINITION OF SERIOUS ADVERSE EVENT (SAE) 
Each adverse event should be assessed for its seriousness. The definition below should be used for this assessment. 
Please note that the term serious adverse event is not synonymous with a “severe” adverse event, which may be 
used to describe the intensity of an event experienced by the participant.  
An adverse event should be classified as serious if it meets any of the following criteria: 
a. Death 
Death was an outcome of the adverse event.  
b. Life-threatening 
The participant was at substantial risk of dying at the time of the adverse event or use or continued 
use of the device. 
c. 
Hospitalization (initial or prolonged) 
Admission to the hospital or prolongation of hospitalization was a result of the adverse event. 
d. Disability or Permanent Damage 
The adverse event resulted in a substantial disruption of a person's ability to conduct normal life 
functions (ie, the adverse event resulted in a significant, persistent or permanent change, 
impairment, damage or disruption in the patient's body function/structure, physical activities and/or 
quality of life). 
e. Congenital Anomaly/Birth Defect 
Exposure to a medical product prior to conception or during pregnancy may have resulted in an 
adverse outcome in the child. 
f. 
Required Intervention to Prevent Permanent Impairment or Damage (Devices) 
Medical or surgical intervention was necessary to preclude permanent impairment of a body 
function, or prevent permanent damage to a body structure (either situation suspected to be due to 
the use of a medical product). 
g. 
Other Serious (Important Medical Events) 
The event does not fit the other outcomes, but the event may jeopardize the participant and may 
require medical or surgical intervention (treatment) to prevent one of the other outcomes. 
 
Non-serious adverse events are all events that do not meet the criteria for a “serious” adverse event. 
 
7.1.3 DEFINITION OF UNANTICIPATED ADVERSE DEVICE EFFECTS (EVENTS) 
An unanticipated adverse device effect is defined as “any serious adverse effect on health or safety, or any life-
threatening problem, or death caused by, or associated with, a device; if that effect, problem, or death was not 
previously identified in nature, severity, or degree of incidence in the investigational plan, or application (including 
supplementary application), or any other unanticipated serious problem associated with a device that relates to the 
rights, safety, or welfare of subjects.” 
7.2 
CLASSIFICATION OF AN EVENT 
 
7.2.1 SEVERITY OF EVENT 

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Each adverse event should be assessed for its severity, or the intensity of an event experienced by the participant, 
using the following classifications: 
1 = Mild  
Discomfort noticed, but no disruption to daily activity 
2 = Moderate 
Discomfort sufficient that reduces or affects normal daily activity 
3 = Severe 
Inability to work or perform normal daily activity 
 
7.2.2 RELATIONSHIP TO THE INVESTIGATIONAL DEVICE 
The investigator should assess the relationship of the adverse event to the investigational device. The relationship 
should be assessed using the categories presented in Table 5. 
TABLE 2: RELATIONSHIP BETWEEN ADVERSE EVENTS AND INVESTIGATIONAL DEVICE 
Definite 
Definite relationship exists between the device/procedure and an adverse 
event 
Probably Related 
A reasonable causal relationship between the device/procedure and an 
adverse event is more likely than not. 
Possibly Related 
A reasonable relationship exists between the device/procedure and an adverse 
event, but the causal relationship is unclear or lacking. 
Not Likely Related 
A temporal relationship exists between the device/procedure and an adverse 
event, but there is no reasonable causal relationship. For example the adverse 
event occurs in a time frame, which makes a causal relationship to device 
treatment improbable. 
Unrelated 
No relationship between treatment with the device/procedure and the 
adverse event exists. 
 
7.2.3 EXPECTEDNESS 
Reported events will be categorized as Expected Treatment Effects if the event meets the definition of any typical 
treatment side-effect of study devices of mild to moderate severity and lasting up to a typical maximum duration. 
7.3 
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
The occurrence of an AE or SAE may come to the attention of study personnel during a study visit or upon review by 
a study monitor. All ETEs and AEs will be captured on the appropriate data form. Information to be collected includes 
event description, date of onset, clinician’s assessment of seriousness and severity, relationship to study 
device/treatment (assessed only by those with the training and authority to make a determination), actions taken, 
and date of event resolution. All AEs occurring while on study must be documented appropriately regardless of 
relationship. All ETEs/AEs assessed as “not yet resolved” must continue to be followed via telephone contact, by 
email, or clinic visit every 7 days or sooner (as per the physician’s direction until event resolution or stabilization or 
tissue resection). 
 
A pre-existing condition should not be reported as an adverse event unless there has been a substantial increase in 
severity or frequency of the problem that has not been attributed to natural history. 
 
Changes in the severity of an event will be documented to allow for a determination if the event should be re-
categorized from an ETE to AE. 
 
The PI will record all reportable events, with start dates, occurring any time after informed consent is obtained until 
seven days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. At each study visit, the 
investigator will inquire about the occurrence of ETEs/AEs/SAEs since the last visit. Events will be followed for 

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outcome information until resolution or stabilization. 
7.4 
REPORTING PROCEDURES 
 
7.4.1 ADVERSE EVENT REPORTING 
Any new medical problem, or an exacerbation of an existing condition, reported from the time the informed consent 
form is signed must be followed until the last study visit after the last study treatment/exposure or until event 
resolution.   
AEs will not be followed up after the final study visit. 
 
7.4.2 SERIOUS ADVERSE EVENT REPORTING 
Serious adverse events must be reported to the Sponsor as soon as possible, preferably within 24 hours but in no 
event later than 72 hours. Any AE considered serious by the PI or Sub-investigator, or which meets the definition 
of an SAE included in Section 7.1.2. Definition of Serious Adverse Event must be documented on an SAE data 
form. 
 
The Sponsor will conduct an investigation. If the Sponsor determines that the investigation presents an unreasonable 
risk to participants, all investigations or parts of the investigation presenting that risk will be terminated as soon as 
possible. The investigator must report serious adverse events to the reviewing IRB according to the IRB regulations 
at the study site. 
 
7.4.3 UNANTICIPATED ADVERSE DEVICE EFFECT REPORTING 
If an unanticipated adverse device effect occurs, the study investigator shall complete the appropriate study-specific 
data form, and submit to the study sponsor and to the reviewing IRB as soon as possible, but in no event later than 
10 working days after the investigator first learns of the effect. The study sponsor contact information is provided in 
Section 1. Key Roles. The study sponsor is responsible for conducting an evaluation of an unanticipated adverse 
device effect and shall report the results of such evaluation to FDA and to all reviewing IRBs and participating 
investigators within 10 working days after the sponsor first receives notice of the effect. Thereafter the sponsor shall 
submit such additional reports concerning the effect (as FDA requests). 
 
7.4.4 REPORTING OF PREGNANCY 
Each pregnancy that starts during the participant’s study participation must be reported by the investigator to the 
Sponsor within 24 hours of learning of its occurrence. Pregnancies and pregnancy follow-up should be reported on 
an Adverse Event form. Pregnancy follow-up should describe the outcome of the pregnancy, including any voluntary 
or spontaneous discontinuation; details of the birth; the presence or absence of any congenital abnormalities, birth 
defects, maternal or newborn complications, and their relationship to the device or treatment/exposure. Each 
pregnancy must be reported as a non-serious AE if the participant has received at least one study 
treatment/exposure.  The following criteria should be followed: 
a. 
If a participant becomes pregnant after the Baseline visit and all study treatments/test spot exposure 
have been completed, the participant should continue to be followed for the duration of the 
pregnancy. 
b. If a participant becomes pregnant after the Baseline visit but before any study treatments/test spot 
exposures, the participant should be exited from the study. 

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c. 
If a participant becomes pregnant after the Baseline visit but before all study treatments/test spot 
exposures have been completed, additional study treatments/test spot exposures should be 
discontinued and the participant should continue to be followed for the duration of the pregnancy. 
 
7.4.5 REPORTING OF DEATHS 
The investigator must notify the Sponsor as soon as possible, preferably within 24 hours but in no event later than 
48 hours, of learning of a participant’s death, regardless of whether the death is related or unrelated to the 
investigational device. The investigator should attempt to determine, as conclusively as possible, whether the death 
is related to the device. The cause of death and the investigator’s discussion regarding whether or not the death was 
device-related should be described in a written report. The investigator must report death to the reviewing IRB 
according to the IRB regulations at the study site. 
8. 
CLINICAL MONITORING 
Clinical site monitoring is conducted to ensure that the rights and well-being of human participants are protected, 
that the reported trial data are accurate, complete, and verifiable, and that the conduct of the trial is in compliance 
with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirement(s). 
• 
Monitoring for this study will be performed by the Sponsor or Sponsor contract monitor. 
• 
Clinical study site and data monitoring will be conducted via both centralized and on-site monitoring. 
o 
Centralized data monitoring will focus primarily on: 
▪ 
Ongoing, real-time review of clinical data supporting safety, and primary and secondary 
study-defined endpoints, specifically: 
• 
Tracking the occurrence of adverse events and expected treatment effects. 
▪ 
Ongoing, real-time review of clinical data as entered on Case Report Forms (CRF):  
• 
Initial study consent was obtained for all enrolled participants;  
• 
Eligibility for study participation of all enrolled participants;  
• 
Verification of protocol compliance and data completeness. 
▪ 
Ongoing, real-time evaluation of data trends to identify outliers, unexpected trends, or 
holes in data collection; 
▪ 
Ongoing, real-time evaluation of study photographs. 
o 
Centralized monitoring requires timely data entry and timely uploading of completed CRFs to the 
study HIPAA compliant cloud-based system (eg ,no later than seven working days after a study visit 
has occurred). 
o 
On- site monitoring visits will include: 
▪ 
Review of primary/secondary endpoint data source documents; 
▪ 
Confirmation that participant randomization is being completed appropriately (if 
applicable); 
▪ 
Confirmation that study blinding is maintained (if applicable); 
▪ 
Confirmation of appropriate execution of the PGAIS, SGAIS, PSQ, or other study-specific 
scales; 
▪ 
Note any other study-specific study design items requiring on-site confirmation. 
o 
General on-site monitoring tasks will include: 
▪ 
Review of study conduct and progress at each investigative site (eg, protocol compliance, 
participant recruitment, etc). 
▪ 
Confirmation that written informed consent was obtained and documented at the time 

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of screening, using an appropriate version of an IRB-approved ICF, and participant 
eligibility is confirmed. 
▪ 
Confirmation that all expected treatment effects, adverse events, and/or protocol 
deviations noted in site records are appropriately documented on study-specific CRFs. 
▪ 
Identification and resolution of any device performance issues; 
▪ 
Review of the investigator’s study records, study management documents and participant 
informed consent documents. 
▪ 
Confirmation that all investigative site personnel with study-related responsibilities are 
adequately trained and that the applicable training records are maintained in the Site 
Regulatory Binder.  
▪ 
Confirmation that study-related responsibilities of site personnel are appropriately 
documented on the Delegation of Responsibility Log and the log is maintained in the Site 
Regulatory Binder. 
▪ 
Reconciliation of the Device Disposition Log against device inventory and confirmation 
that study devices are kept in a secure location. 
▪ 
Confirmation that required regulatory documents are present in the Site Regulatory 
Binder and are current and correct.  
▪ 
Ensure that all findings, conclusions, and any actions taken to correct deficiencies noted 
during an on-site monitoring visit are documented in a site monitoring report.  
o 
On-site monitoring frequency 
▪ 
An on-site monitoring visit will be completed at each study site at least one time during 
the course of this clinical trial. 
▪ 
The frequency of site monitoring visits may be adjusted based on a number of factors, 
including but not limited to:  
• 
Duration of the study; 
• 
Number of participants enrolled; 
• 
Number of investigators/sites;  
• 
Complexity of the study; 
• 
The level of the study site’s experience in conducting and overseeing clinical 
trials;  
• 
The quality of the data documented on study-specific data forms and entered 
into the study database; 
• 
Number of outstanding issues from previous visits. 
9. STATISTICAL ANALYSIS 
9.1 
STATISTICAL AND ANALYTICAL PLANS 
The primary analysis of efficacy will be by study group and will be based on the evaluable treated participants; 
hence, only those participants who received complete study treatments and completed a 30-day/90-day follow-up 
visit post-the-final-treatment-visit, and who have evaluable post-treatment images, will be included in the analysis. 
Analyses of safety will include all participants who received (complete or incomplete) study treatment.  
9.2 
ANALYSIS DATASETS 

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The following analysis sets will be defined for the statistical analysis of this investigation:  
 
Safety Evaluation Set (SES)  
Subset of all participants who received the investigational treatment.  
 
Full Analysis Set (FAS)  
Subset of participants in SES that received complete treatments have primary effectiveness data available. 
 
Per Protocol Set (PPS)  
Subset of all participants who received complete treatments and have completed the study without major protocol 
deviations. 
 
9.3 
DATA SUMMARY 
At the conclusion of the study the data will be analyzed and summarized in a report.  Categorical values (such as sex, 
ethnicity, satisfaction results, etc.) will have both their number of occurrences as well as the frequency of those 
occurrences reported.  For continuous variables (such as age, treatment pain scores, etc.) the minimum, maximum, 
average, median, and standard deviation will all be reported. 
10. SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA / 
DOCUMENTS 
Source documents are defined as the results of original observations and activities of a clinical investigation. Source 
documents will include, but are not limited to, study-specific data forms, progress notes, electronic data, computer 
printouts, screening logs, and recorded data from automated instruments. All source documents pertaining to this 
study will be maintained by the investigators and made available for inspection by authorized persons. 
Following written SOPs, the clinical study monitors will verify that the clinical trial is conducted, and data are 
generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable 
regulatory requirements. 
The investigational site will provide direct access to all trial related sites, source data/documents, and reports for 
the purpose of monitoring and auditing by the sponsor, and inspection by local and regulatory authorities. 
11. ETHICS/PROTECTION OF HUMAN PARTICIPANTS 
11.1 ETHICAL STANDARD 
This clinical study will be conducted in accordance with the Protection of Human Subjects Regulations, including 
Subpart B Informed Consent of Human Subjects (21 CFR Part 50); the Institutional Review Board Regulations (21 CFR 
Part 56); the Financial Disclosure by Clinical Investigators Regulations (21 CFR Part 54); and the Investigational Device 
Exemptions Regulations (21 CRF Part 812), and the ICH E6. 
11.2 INSTITUTIONAL REVIEW BOARD 
Prior to initiation of any study procedures, the protocol, informed consent, and recruitment materials, and all 
participant materials will be submitted to a duly constituted IRB for view and approval. In addition, any amendments 

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to the protocol or Informed Consent Form will be reviewed and approved by the IRB. The Sponsor must receive a 
letter documenting IRB approval at the clinical site prior to the initiation of the study. 
The investigator is responsible for providing the appropriate reports to its reviewing IRB during the course of the 
clinical study. These reports will include: 
1. Informing the IRB of the study progress periodically as required, but at least annually; 
2. Reporting any unanticipated adverse device effects within 10 working days of first learning of the event; 
3. Reporting any deviations from the clinical protocol to protect the life or well-being of a participant, in the 
case of an emergency, within five working days after the emergency occurred; 
4. Reporting the use of the device without obtaining informed consent from a participant within five working 
days of the event; and  
5. Providing any other reports requested by the IRB. 
The IRB must be notified of study completion within 30 days of the final visit of the last participant and should be 
provided with a summary of the results of the study by the investigator. 
11.3 INFORMED CONSENT PROCESS 
 
11.3.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO PARTICIPANTS 
Consent forms describing in detail the study device, study procedures, and risks are given to the participant and 
written documentation of informed consent is required prior to starting intervention/administering study product.  
 
11.3.2 CONSENT PROCEDURES AND DOCUMENTATION 
Informed consent will be obtained from all participants prior to study participation. Informed consent is a process 
that is initiated prior to the individual’s agreeing to participate in the study and continues throughout the individual’s 
study participation. Extensive discussion of risks and possible benefits of participation will be provided to each 
participant. Consent forms will be IRB-approved, and the participant will be asked to read and review the document. The 
investigator, or investigator-delegated study personnel, will explain the research study to the participant and answer 
any questions that may arise. All participants will receive a verbal explanation in terms suited to their comprehension of 
the purposes, procedures, and potential risks of the study and of their rights as research participants. Participants will 
have the opportunity to carefully review the written consent form and ask questions prior to signing. The participants 
should have the opportunity to discuss the study with their surrogates or think about it prior to agreeing to participate. 
The participant will sign the informed consent document prior to any procedures being done specifically for the study. 
The participants may withdraw consent at any time throughout the course of the trial. A copy of the informed consent 
document will be given to the participants for their records. The rights and welfare of the participants will be protected 
by emphasizing to them that the quality of their medical care will not be adversely affected if they decline to 
participate in this study. 
11.4 PARTICIPANT AND DATA CONFIDENTIALITY 
All information generated in this study must be considered highly confidential and must not be disclosed to any 
persons not directly concerned with the study without prior written permission from the Sponsor. Authorized 
regulatory officials and Sponsor personnel (or its representatives) will be allowed full access to inspect the records. 
All investigational devices and/or other materials collected will be used solely in accordance with this protocol, 
unless otherwise agreed to in writing by the Sponsor. 

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Participants should be identified only by initials and unique participant numbers on study-specific data forms. If 
necessary, their full names may be made known to a regulatory agency or other authorized officials. 
12. DATA HANDLING AND RECORD KEEPING 
12.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES 
Data collection is the responsibility of the clinical trial staff at the site, under the supervision of the site PI. The 
investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the data reported. 
During each participant’s visit to the clinic, study data will be documented by study personnel on study-specific data 
forms (CRFs). In addition, study personnel will record progress notes to document all significant observations, and 
any contact with a participant by telephone or other means that provides significant clinical information will also be 
documented in the progress notes as described above. 
For transmission to the Sponsor, information from the study progress notes and other source documents will be 
promptly transcribed to study-specific data forms (CRFs). In this clinical trial, study-specific data forms (CRFs) may 
also serve as source documents. Transcription of study data onto study-specific data forms should be completed and 
uploaded within seven days of the study visit. 
Copies of the CRF serving as source documents must be maintained for each participant enrolled in the study. Data 
reported in the CRF derived from source documents should be consistent with the source documents or the 
discrepancies should be explained and captured in a progress note and maintained in the participant’s official study 
record. 
Any changes to information in the study progress notes, other source documents, and data forms will be initialed 
and dated in ink on the day the change is made by a site study staff member authorized to make the change. Changes 
will be made by striking a single line through erroneous data, and clearly entering the correct data. If the reason for 
the change is not apparent, a brief explanation for the change will be written in the source documentation by the 
clinician. 
12.2 INVESTIGATOR RECORDS AND REPORTS 
12.2.1 INVESTIGATOR RECORDS 
Prior to participation in the investigation, the investigator must provide the following documentation to the Sponsor:  
• 
Investigator Agreement, signed by the investigator, which lists any physicians who will be involved in 
conducting the investigation under the direction of the primary investigator; 
• 
A copy of the principal investigator’s, sub-investigator’s, other delegated study clinicians’ curriculum vitae; 
• 
A letter signed by the chairperson of the IRB overseeing the conduct of this study indicating that the IRB 
has reviewed and approved this investigational plan; and 
• 
A copy of the IRB-approved Informed Consent Form. 
During the study, investigators are required to maintain on file the following accurate, complete, and current records 
relating to this study as described in 21 CFR §812.140. A summary of these records is listed below: 
• 
All correspondence and required reports, which pertain to the study. 
• 
Records of receipt, use, or disposition of study devices, including the type and quantity of devices; the dates 
of receipt; the serial numbers; the names of all persons who received, used, or disposed of each device; 
and why and how many units of the device have been returned to the Sponsor, repaired, or otherwise 
disposed. 
• 
Records of each participant’s case history and exposure to the device. 

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• 
Signed and dated consent forms. 
• 
Relevant observations, including records concerning adverse events, condition of each participant upon 
entering and results of diagnostic tests. 
• 
Study-specific data forms and corrections to the forms. 
• 
Protocol and amendments. 
• 
Participant recruiting materials. 
• 
Investigator curriculum vitae. 
 
12.2.2 INVESTIGATOR REPORTS 
Investigators are required to prepare and submit to the Sponsor the following complete, accurate, and timely reports 
on this investigation, when required. These reports, which are listed below, are required by 21 CFR §812.150; 
additional reports may be requested by the Sponsor: 
• 
The investigator will notify the Sponsor of a participant death occurring during the investigation, as soon as 
possible, preferably within 24 hours of learning of the participant’s death, but in no event later than 48 
hours. The investigator will notify the reviewing IRB of a participant death as specified by the IRB. 
• 
The investigator will notify the Sponsor of any unanticipated adverse device effects within 48 hours after 
learning of the effect. The investigator will notify its reviewing IRB of any unanticipated adverse device 
effects, as soon as possible, but no later than 10 working days after learning of the effect. 
• 
The investigator will notify the Sponsor of the withdrawal of IRB approval, as soon as possible, but no later 
than five working days after learning of the withdrawal. 
• 
The investigator will provide current progress reports to the Sponsor and reviewing IRB at regular intervals 
and at least on an annual basis. 
• 
The investigator will notify the Sponsor and reviewing IRB of any deviation from the investigational plan to 
protect the life and physical well-being of a participant in an emergency, as soon as possible, but no later 
than five working days after the emergency occurred. 
• 
The investigator will notify the Sponsor and reviewing IRB that an informed consent was not obtained from 
a participant, as soon as possible, but no later than five working days after such an occurrence. 
The investigator will provide a final summary report to the Sponsor and reviewing IRB within three months after 
termination or completion of the study.The investigator will provide any other information upon the request of 
an IRB, FDA, or the Sponsor. 
12.3 STUDY RECORDS RETENTION 
The investigator is responsible for retaining the necessary records, including a copy of the protocol, device labeling, 
study-specific data forms, medical records, original reports of test results, all study-related correspondence, a record 
of written informed consent, and any other documents pertaining to the conduct of this study. 
FDA regulations require all investigators participating in investigational device studies to maintain detailed clinical 
records during the investigation and for a period of at least two years after the latter of the following two dates: 
1. The date on which the investigation is terminated or complete; or 
2. The date the records are no longer required for purposes of supporting a premarket approval application. 
The investigator must not dispose of any records relevant to this study without either: 
1. Obtaining written permission from the Sponsor; or 
2. Providing an opportunity for the Sponsor to collect such records. 

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The investigator shall take responsibility for maintaining adequate and accurate electronic or hard copy source 
documents of all observations and data generated during this study. Such documentation is subjected to inspection 
by the Sponsor and the FDA. 
12.4 PROTOCOL DEVIATIONS 
This study should be conducted as described in this protocol, except for an emergency situation in which the 
protection, safety, and well-being of a participant requires a protocol deviation, based on the judgment of the 
investigator (or a responsible, appropriately trained professional designated by the investigator). If the deviation 
from the protocol is necessary to protect the physical well-being of a participant in an emergency, such protocol 
deviations must be reported to the Sponsor and the reviewing IRB as soon as possible, but no later than five working 
days after the emergency occurred.  
In the event of a significant deviation from the protocol due to an accident or mistake, the investigator or designee 
must contact the Sponsor at the earliest possible time by telephone to discuss the deviation and its impact on the 
study and participant continuation in the study. These discussions will be documented by the investigator and the 
Sponsor and reviewed by the monitor. 
12.5 PUBLICATION AND DATA SHARING POLICY 
The data produced by this Lutronic‐sponsored study is the sole property of Lutronic. Thereby, abstracts, 
publications and presentations of this data must be pre‐approved by Lutronic in writing (e‐mail approval is 
acceptable). The Sponsor must also be provided with the opportunity to review all investigator‐prepared abstracts, 
publications, or presentations.  A period of thirty (30) days for presentational materials and abstracts and forty‐
five (45) days for manuscripts will be required for review and comment by the Sponsor’s Clinical Research 
Department. These requirements acknowledge the Sponsor's responsibility to evaluate such publications for 
their accuracy, to ascertain whether Confidential Information is being inappropriately released, to provide the 
Principal Investigator with information which may not yet have been available to him/her, and to provide input 
from co‐authors regarding content and conclusions of the publication or presentation. If requested in writing by 
the Sponsor, the Institution will withhold publication to protect the potential patentability of any invention 
described therein and/or make available to fulfill regulatory requirements. 
Notwithstanding the foregoing, the Investigator agrees that if the study is part of a multi‐center study, the first 
publication of the results of the study shall be made in conjunction with the results from the Investigators at the 
other study centers as a multi‐center publication. 
13. STUDY ADMINISTRATION  
13.1  STUDY INVESTIGATORS 
All Investigators will be experienced with aesthetic treatments using a variety of accepted clinical modalities. 
13.2 AMENDMENT POLICY 
The investigator will not make any changes to this protocol without prior written consent from the Sponsor and 
subsequent approval by the IRB, except if the deviation from the protocol is necessary to protect the life and physical 
well-being of a participant in an emergency. Such protocol deviations must be reported to the Sponsor and the 
reviewing IRB as soon as possible, but no later than five working days after the emergency occurred. 

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 Any permanent change to the protocol, whether it is an overall change or a change for specific study center(s), must 
be handled as a protocol amendment. Any amendment to the protocol that appears necessary as the study 
progresses will be fully discussed by the investigator(s) and the Sponsor. If agreement is reached regarding the need 
for an amendment, the Sponsor will write the amendment. The written amendment must be submitted to the 
chairman of the IRB identified with this responsibility. Except for “administrative amendments,” investigators must 
await IRB approval of protocol amendments before implementing the change(s). Administrative amendments are 
defined to have no effect on the validity of the data or information resulting from the completion of the approved 
protocol, or the relationship of likely patient risk to benefit relied upon to approve the protocol; the scientific 
soundness of the investigational plan or protocol; and the right, safety or welfare of the human participants involved 
in the investigation. 
When, in judgment of the chairman of the IRB, the investigators, and/or the Sponsor, the amendment to the protocol 
substantially alters the study design and/or increases the potential risk to the participant, the currently approved 
written Informed Consent Form will require similar modification. In such cases, repeat informed consent will be 
obtained from participants enrolled in the study before continued participation. 
14. CONFLICT OF INTEREST POLICY 
The independence of this study from any actual or perceived influence is critical. Therefore, any actual conflict of interest 
of persons who have a role in the design, conduct, analysis, publication, or any aspect of this trial will be disclosed and 
managed. Furthermore, persons who have a perceived conflict of interest will be required to have such conflicts 
managed in a way that is appropriate to their participation in the trial.  
 
REFERENCES 
 
1. Dibernardo, Gabriella & DiBernardo, Barry. (2018). Prediction of Treatment Outcomes for Neck 
Rejuvenation Utilizing a Unique Classification System of Treatment Approach Using a 1440-nm Side-Firing 
Laser. Aesthetic Surgery Journal. 38. S43-S51. 10.1093/asj/sjy066. 
 
 

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APPENDIX A: DEVICE OPERATOR MANUAL 
 
See attached document 
 
 
 
 

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APPENDIX B: MOSAIC ULTRA TREATMENT GUIDELINES 
 
See attached document 
 
 

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PROTOCOL REVISIONS  LOG 
VERSION 
DATE 
SIGNIFICANT REVISIONS 
V1.0 
27 October 2022 
Initial IRB Submission 
V1.1 
7 November 2022 
Fixed page numbering in footer, clarified Dr. Ibrahimi as PI 
V1.2 
12 December 2022 
Expanded the biopsy portion of the study into a more detailed 
secondary study group; updated language as appropriate.  
Broaded enrollement age from 20-60 to 18-60. 
V1.3 
1 June 2023 
Expanded protocol to include a second site.  Increased biopsy 
group enrollment to 30 to account for data required by FDA.