Feasibility Study To Collect Safety And Preliminary Efficacy Data For A Radiofrequency Microneedling Device
Phase: NA
Conditions: Wrinkles, Fine Lines, Crepey Skin, Acne Scars, Active Acne, Enlarged Pores, Loose Skin
Sponsor: Cynosure, Inc.

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Feasibility Study To Collect Safety And Preliminary Efficacy Data For A 
Radiofrequency Microneedling Device
NCT05254210 
Document Date: February 2, 2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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INVESTIGATIONAL PLAN 
 
PROTOCOL #: CYN20-RF-MN-PROFILES 
 
FEASIBILITY STUDY TO COLLECT SAFETY AND PRELIMINARY EFFICACY DATA 
FOR A RADIOFREQUENCY MICRONEEDLING DEVICE  
 
 
 
 
CONFIDENTIAL 
 
THIS INVESTIGATIONAL PLAN CONTAINS CONFIDENTIAL INFORMATION FOR USE BY 
THE INVESTIGATORS AND THEIR DISIGNATED REPRESENTITIVES PARTICIPATING IN 
THIS STUDY.  IT SHOULD BE HELD CONFIDENTIAL AND MAINTAINED IN A SECURE 
LOCATION.  IT SHOULD NOT BE COPIED OR MADE AVAILABLE FOR REVIEW BY ANY 
UNAUTHORIZED ENTITY. 
 
 
 
 
 
 
 
SPONSOR: 
CYNOSURE, LLC 
5 CARLISLE ROAD 
WESTFORD, MA 01886 
PHONE: 800-886-2966 
FAX: 978-256-6556 
 
 
 
 

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FEASIBILITY STUDY TO COLLECT SAFETY AND PRELIMINARY EFFICACY DATA FOR A 
RADIOFREQUENCY MICRONEEDLING DEVICE 
 
INVESTIGATOR AGREEMENT 
 
I agree to conduct the study in accordance with the relevant, current protocol and will only make changes in a protocol after notifying the 
sponsor, except when necessary to protect the safety, rights, or welfare of subjects. 
 
I agree to personally conduct or supervise the described investigation. 
 
I agree to inform any patients, or any persons used as controls if applicable, that the device(s) is/are being used for investigational purposes 
and I will ensure that the requirements relating to obtaining informed consent in and institutional review board (IRB) review and approval 
are met. 
 
I agree to report to the sponsor adverse experiences that occur in the course of the investigations.  I have read and understand the information 
in the device manual, including the potential risks and side effects of the device. 
 
I agree to ensure that all associates, colleagues, and employees assisting in the conduct of the study are informed about their obligations in 
meeting the above commitments.  
 
I agree to maintain adequate and accurate records and to make those records available for inspection. I further agree that Cynosure, Inc. or 
their designees shall have access to any source documents from which case report form information may have been generated. 
 
I will ensure that an IRB that complies with the requirements of 21 CFR Part 56 will be responsible for the initial and continuing review 
and approval of the clinical investigation. I also agree to promptly report to the IRB all changes in the research activity and all unanticipated 
problems involving risks to human subjects or others.  Additionally, I will not make any changes in the research without IRB approval, 
except where necessary to eliminate apparent immediate hazards to human subjects. 
 
I agree to comply with all other requirements regarding the obligations of clinical investigators. 
 
I will comply with the International Conference on Harmonization (ICH), Good Clinical Practice (GCP) guidance E6, FDA Good Clinical 
Practice Regulations (21 CFR parts 50, 56, and 812), Declaration of Helsinki (DoH) and the Health Human Service (HHS) Belmont Study 
Principals and Guidelines during the conduct of this study. 
 
I have read the foregoing protocol and agree that it contains all necessary details for carrying out this study. I will conduct the study as 
outlined herein and will complete the study within the time designated. 
 
I will provide copies of the protocol and all pertinent information to all individuals responsible to me who assist in the conduct of this 
study.  I will discuss this material with them to ensure they are fully informed regarding the study device the conduct of the study.  
 
I will disclose financial arrangements and interests in accordance with Financial Disclosure Rules (21 CFR part 54) and FDA Form 3455. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Investigator’s Signature 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
Name of Investigator (Typed or Printed) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Address of Investigator (Typed or Printed) 
 

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SITE #1 CONTACT INFORMATION: 
Principal Investigator Information: 
Peyman Soliemanzadeh, M.D. 
Profiles Beverly Hills 
 9201 W Sunset Blvd Unit M130,  
West Hollywood, CA 90069 
Phone: 310-276-6800 
Email: peyman@joliemd.com 
 
 
SPONSOR CONTACT INFORMATION: 
Jennifer Civiok 
Director, Clinical Development 
Cynosure, LLC 
5 Carlisle Road 
Westford, MA 01886 
Phone: 800-886-2966 
Fax: 978-256-6556 
Email: jennifer.civiok@cynosure.com 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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TABLE OF CONTENTS 
1.0 
PURPOSE  
1.1 
Name and Intended Use 
1.2 
Objectives  
1.3 
Duration of the Investigation 
2.0 
PROTOCOL  
2.1 
Protocol Methodology and Analysis 
2.2 
Protocol Study Design  
2.3 
Subject Selection Criteria 
2.4 
Screening 
2.5 
Informed Consent Process and Enrollment 
2.6 
Pre-Treatment Procedures 
2.7 
Treatment Procedures 
2.8 
Post Treatment Procedures 
2.9 
Follow Up 
2.10 
Unscheduled Visits  
2.11 
Replacement of Subjects 
2.12 
Schedule of Visits and Procedures  
2.13 
Evaluation Methods 
2.14 
Adverse Event Recording  
2.15 
Statistical Analysis 
3.0 
RISK ANALYSIS AND MANAGEMENT  
4.0 
DEVICE DESCRIPTION AND SPECIFICATIONS  
5.0 
MONITORING PROCEDURES  
6.0 
LABELING  
7.0 
CONSENT MATERIALS 
8.0 
INSTITUTIONAL REVIEW BOARD INFORMATION 
9.0 
OTHER INSTITUTIONS  
10.0 
ADDITIONAL RECORDS AND REPORTS 
11.0 
PREGNANCY 
12.0 
SUBJECT WITHDRAWAL 
13.0 
PHOTOGRAPHY 
14.0 
ADVERSE REACTIONS DEFINITIONS AND REPORTING REQUIREMENTS 
15.0 
PROTOCOL DEVIATIONS 
16.0 
CONFIDENTIALITY AND DISCLOSURE OF MEDICAL INFORMATION 
17.0 
CLINICAL RESEARCH CONDUCT  
18.0 
REPORTING FOR THE STUDY 
19.0 
DISCLOSURE 
20.0 
RESPONSIBILITY OF THE INVESTIGATOR 
21.0 
PROCEDURE FOR AMMENDMENTS TO PROTOCOL  
22.0 
TERMINATION OF STUDY 
23.0 
DATA SECURITY 
24.0 
REPORT OF PRIOR INVESTIGATIONS 
 
APPENDICES 
A. 
Protocol Revisions Tracker 
B. 
Universal Pain Assessment Tool 
 
ATTACHMENTS/REFERENCES 

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I. 
Operator Manual for the Potenza™ device  
II. 
Clinical Reference Guide for the Potenza™ 
III. 
Informed Consent Form  
IV. 
Pre and Post Treatment Instructions 

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1.0       PURPOSE 
1.1 Name and Intended Use  
The device used in this study is called the Potenza™ device. 
 
The intended use of the Potenza™ device is to collect clinical data for brow lifting and/or 
treatment of dermatologic conditions in which electrocoagulation and hemostasis is a viable 
mechanism for means of improvement. 
 
1.2 Objectives   
1. Primary Objective:  
 Assessment of safety of the study device through the collection of side effects 
throughout the study. 
2. Secondary Objectives: 
 Evaluation of baseline photographs compared to post treatment images.  
3. Assessments: 
 Treatment discomfort evaluation 
 Subject satisfaction questionnaire 
 Physician questionnaire 
 Treatment area photography 
 
1.3 Duration of the Investigation 
The sponsor anticipates that all subjects can be enrolled within 6 months.  If subject participates in 
all required visits, then the subject’s participation in this study may last up to 6 months. It is 
anticipated that it will take approximately 3 months to analyze the data collected during this study. 
The total duration of this study is anticipated to last approximately 15 months. 
 
2.0 
PROTOCOL 
2.1 Protocol Methodology and Analysis 
Methodology: 
Subjects are to be enrolled in this clinical study if they are 18 - 60 years old. Up to 10 subjects will 
be enrolled at 1 study center. Subjects may receive up to 3 treatments with the Potenza™ device if 
they are willing to receive treatment for brow lifting and/or present with conditions such as, but not 
limited to; Wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, loose skin on 
the face, neck and/or body.  
 
Subjects will attend a screening/pretreatment visit which may be performed on the same day as the 
treatment visit. Subjects will receive up to 3 treatments. All subjects will receive a phone call 1 
week (1-10 days) after each treatment to record side effects. Subjects will be required to return for 
a follow-up visit 30 days after the final treatment. Subjects may also attend an optional follow up 
visit 90 days after the final treatment. An unscheduled visit or phone call may be performed at any 
time during the study at the request of the subject or as deemed necessary by the site Investigator. 
 
 
 

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Analysis: 
Upcoming generations are proving to have an interest in aesthetic dermatology treatments and will 
drive demand for innovated products, procedures, and practice design.1 Due to this shift in patient 
base, practices need to evolve to adapt to the newer generational ideologies. There have been rapid 
advances in RF technology over the past few years and the nonsurgical treatment using this energy 
source offers great promise to our aging population.2 Radiofrequency micro needling technology 
for the treatment of dermatologic conditions needs to be further investigated to optimize treatment 
parameters for safe and effective non-ablative treatments.  
 
Relevance: 
Does not apply to this study – feasibility study. 
 
Testability: 
Does not apply to this study – feasibility study. 
 
Compatibility: 
Does not apply to this study – feasibility study. 
 
Predictive power: 
Does not apply to this study – feasibility study. 
 
2.2 Protocol Study Design 
This is a prospective, open label, single center clinical study 
 
 
2.3 Subject Selection Criteria 
 
Subjects will meet the criteria described below: 
 
Inclusion Criteria: 
 A healthy, non-smoking male or female between the age of 18-60 years old. 
 Fitzpatrick skin type I to VI. 
 Understands and accepts obligation not to receive any other procedures on the treatment 
area through the length of the study. 
 Understands and accepts the obligation and is logistically able to be present for all visits. 
 Is willing to comply with all requirements of the study and sign the informed consent 
document. 
 
Exclusion Criteria: 
 Is pregnant or of childbearing potential and not using medically effective birth control, or 
has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy 
during the study. 
 The subject is currently enrolled in an investigational drug or device trial or has received an 
investigational drug or been treated with an investigational device within in the area to be 
treated 3 months prior to entering this study. 
 The subject has a pacemaker. 

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 The subject had previous use of gold thread skin rejuvenation. 
 The subject has a cut, wound, or infected skin on the area to be treated (but skin eruptions 
may be treated). 
 The subject has a metal implant that interferes with the transmission of energy to the 
electrical field. 
 The subject has any embedded electronic devices that give or receive a signal.  
 The subject has Implantable Cardiac Defibrillators (ICD) or Cardiac Resynchronization 
Therapy (CRT) devices: treatment may interfere with the functionality of the device and/or 
damage the electronic implant. 
 The subject is allergic to adhesives such as glues on medical tape: they should be alerted 
that a rash may occur on the neutral electronic monitoring pad (NEM or neutral pad) site, 
and an over-the-counter preparation may be used to treat the area. 
 The subject is allergic to gold. 
 The subject has an unrealistic expectation of the results: this is not plastic surgery, and all 
subjects should be fully informed of the treatment’s expected results. 
 The subject has nerve insensitivity to heat in the treatment area or in the neutral pad 
placement area. 
 The subject has severe laxity or sagging that causes redundant folds of tissue or hanging 
skin in the area to be treated: this treatment will be ineffective. 
 The subject has used Accutane (isotretinoin) six to twelve months prior to treatment, as this 
can thin the skin and make it brittle. 
 The subject is taking aspirin or are currently taking antiplatelets, thrombolytics, anti-
inflammatories or anticoagulants. 
 The subject has a history of bleeding coagulopathies. 
 The subject is allergic to topical anesthetic. 
 The subject has any of the following conditions: 
o Diabetes 
o Epilepsy 
o Autoimmune disease 
o Herpes simplex 
o HIV 
o Hypertension 
o Dermatitis 
 The subject has keloid formation propensity. 
 Subjects with electronic implants such as cardiac defibrillator. It may interfere with 
operation of electronic implants or damage the implants, causing risks. 
 The subject has any condition or is in a situation which in the investigators opinion may put 
the subject at significant risk, may confound study results or may interfere significantly 
with the subject’s participation. 
 
Cautionary Criteria: 
 The subject is prone to fever blisters: they should receive a prophylactic antiviral 
medication regimen prior to treatment.  

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 The subject has lesions in the treatment area that have not been evaluated and diagnosed: 
they should be evaluated prior to the treatment day.  
 The subject has malignant disease (excluding skin malignancies). 
 The subject has used retinoids in the last seven days in the area to be treated: retinoids can 
create erythema and cause the skin to become heat sensitive. 
 The subject has used any chemical peels in the last two to three months in the treatment 
area: subjects should wait until any remaining erythema or side effects have resolved. 
 The subject has tattoos, permanent makeup, and permanent brows in the treatment area: 
caution must be used. (The ink used in these applications is unregulated and may have 
metallic components.) 
 The subject has a neuropathic disorder, impaired skin sensation or diabetic neuropathy. 
 The subject has received fillers or neurotoxin injections: subjects should wait two weeks 
before receiving a Potenza treatment. 
 
Be sure to list all concomitant medications or procedures permitted before, during and after the 
trial.  
 
Subjects will be recruited for the study through existing patient database and advertisements. 
 
Subject populations will not be eligible to participate in the study if they are vulnerable 
populations such as; children, pregnant women, prisoners, institutionalized individuals, and any 
persons requiring a legally authorized representative as part of the consenting process. 
 
Subject population characteristics that will not be eligible to participate in participate in the study 
include non-English speaking individuals and people who cannot read or comprehend English. 
Employees of the Investigator will may participate in the study.  
 
2.4 Screening  
Subjects will be asked questions about their medical history, may have a limited physical and their 
inclusion/exclusion criteria will be verified.  Discontinuation of any concomitant medications, 
pretreatment instructions and post treatment instruction will be reviewed with the subject.  
 
Procedure for the Limited Physical Exam: 
If the investigator determines that a limited exam is necessary, the exam will be like a basic annual 
physical exam performed by a primary care doctor to determine general overall health. The limited 
medical exam may include all or any of the following; vital signs such as blood pressure, heart 
rate, respiratory rate and body temperature, general appearance, listening to the heart, lungs and 
abdomen with a stethoscope, head and neck exam, in addition to examining the throat, tonsils, 
teeth, ears, eyes and nose as well as a neurological exam such as testing muscle strength, reflexes, 
balance, sensory changes of the extremities and mental state. 
 
 
2.5 Informed Consent Process and Enrollment 
Subjects will be asked to review the pre and post treatment instructions prior to signing the 
informed consent and their involvement in the study. Subjects will be informed of standard 
COVID-19 procedures that adhere to federal and state guidelines. Subjects who sign the informed 

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consent will be screened to confirm eligibility and if eligible, will be assigned a subject 
identification number. Subjects will be de-identified through their subject identification number, 
which will be stored in a secure location.  Subject identification numbers will be generated 
chronologically and assigned only to subjects who have met all the study selection criteria and 
have signed the informed consent form.  The informed consent will be obtained prior to a subject’s 
involvement in any study related procedures.  A subject will be considered enrolled in the study 
once they have signed the informed consent form. Employees of the Sponsor will be required to 
sign both the main informed consent form as well as an employee consent form.  
 
2.6 Pre-Treatment Procedures 
If the subject is of childbearing potential (i.e. females not post-menopausal or not surgically 
sterile), then they will be asked if they are pregnant, the date of their last menstrual cycle, and 
perform a pregnancy test. If the treatment is on the abdomen, a urine pregnancy test must be 
performed before each treatment. A urine pregnancy test may be conducted at the Investigators 
discretion during the study. If a urine pregnancy test is conducted, then a negative result must be 
obtained within 24 hours prior to the treatment. 
 
Urine Pregnancy Test Procedure: 
1. A urine sample is tested mid-stream or by cup sample with an indicator stick.  
2. Negative results are indicated on the indicator stick.  
 
 The following Pre-Treatment instructions will be reviewed: 
o Remove all jewelry and makeup, including eye makeup, lotions or sun block and wash 
facial area prior to treatment.  
o Keep hydrated by drinking water (at least 8 cups daily) or hydrating fluids, such as 
Gatorade, and avoid drinking alcohol for several days in advance. 
o For seven days prior to treatment, at the physician’s discretion, avoid therapies that may 
cause erythema (redness) or irritation such as retinols or products containing Isotretinoin or 
any exfoliating acid.  
o Shave visible hair from the treatment area. Male beards should be shaved day of treatment.  
 Photographs will be taken prior to the first treatment.  
 
2.7 Treatment Procedures 
 Procedure for the Potenza™ device: 
o The treatment area will be identified and may be marked with a surgical marker. 
o Anesthesia (such as a topical), air cooling, and/or Nitronox will be used at the 
discretion of the Investigator.  
o A neutral pad will be placed in an area determined by the Clinician to maintain standard 
energy settings and requires less power from the device during the treatment.  
o Test spots may be performed prior to the first treatment. Test spots may be performed 
prior to the first treatment. It will follow a similar procedure to treatment but only in an 
inconspicuous place, such as behind the ear, in an area no larger than 2in x 2in. 
o The tip will be placed in contact with the skin.  
o The entire defined treatment area will then be treated as instructed by the Operator’s 
Manual. 

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o Parameters may be adjusted throughout the treatment and will determined by the 
Clinician. 
o Subjects will be asked to report the general level of treatment discomfort/pain on a 
scale of 0 (none) to 10 (maximum intolerable pain). 
 Photographs may be taken during treatment.  
 Subject questionnaires may be performed during treatment. 
 Subjects may receive up to 3 treatments every 4 weeks (+/- 2 weeks) which will be determined 
by the Investigator. 
 The additional treatments will follow the same procedure. 
 
2.8 Post Treatment Procedures 
 Adverse events will be documented after treatment. 
 Clinician and subject treatment experience questionnaires may be performed.  
 The following post treatment instructions will be reviewed:  
o Do not scrub or exfoliate the skin. 
o Wash the area with warm water and a mild cleanser, such as Cetaphil. 
o Do not apply liquid makeup for 24 hours; mineral makeup is acceptable after the 
redness resolves. 
o If redness after treatment persists, use an ice pack (or a bag of frozen peas) at home; 
always use a protective barrier, such as a face cloth, between the skin and the ice pack. 
o Before touching your face or applying facial products, be sure to wash your hands well: 
there are micro-pathways opened into the dermis and hands will introduce bacteria. 
o If skin feels tight or dry, apply moisturizing cream as often as desired. 
o If you currently have skin breakouts, you may find that the condition may temporarily 
worsen due to inflammation or swelling. 
o Do not pick at treated tissue: doing so may result in hyper- or hypopigmentation. 
o Avoid ultraviolet rays and apply sunblock >30 SPF UV A/B daily. 
o Avoid alcohol consumption if possible. 
o For 24 hours, refrain from cardio exercise or activities that increase the body 
temperature, i.e. hot yoga, saunas etc. 
o Contact your practitioner if any problems develop: concerns regarding rash, itching, 
redness, etc., for more than 24 hours. 
 
2.9 Follow Up 
 All subjects will receive a phone call 1 week (1-10 days) after each treatment to record side 
effects.  
 The study subjects are required to return to the investigative site for a follow-up evaluation 
at 30 days post last treatment.  
 Subjects may be asked to return for an optional follow up visit 90 days post last treatment. 
 Photographs will be taken, subject and physician questionnaires will be performed, and 
adverse events will be documented at all follow up visits.  
 Some subjects may have an incomplete response or no response by the end of the study. At 
the end of the study, treatments using an FDA approved/cleared treatment method may be 
discussed with the subject and obtained at the cost of the subject. 

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2.10 Unscheduled Visits 
An unscheduled visit may be performed at any time during the study at the subject’s request or as 
deemed necessary by the site Investigator. The date and reason for the unscheduled visit will be 
recorded in the source documentation. 
 
2.11 Replacement of Subjects 
Replacement of subjects who have withdrawn or been withdrawn from the study will be allowed to 
be replaced with prior approval from the sponsor and/or IRB.

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2.12 Schedule of Visits and Procedures 
 
Visit #1 
Visit #2-4 
Phone Call  
Visit #5 
Visit #6 
(optional) 
Procedure 
Screening 
and 
Pretreatment 
Procedures* 
Treatment 
Visit(s) 1-3 
Every 4 
Weeks  
(+/- 2 weeks)
1 Week 
Post Each Tx 
(1-10 Days) 
Follow Up 
30 Days 
Post Last Tx 
(+/- 1 Week) 
Follow Up 
90 Days 
Post Last Tx 
(+/- 2 Weeks)
Medical History
X
Pregnancy 
Verification
X 
X** 
 
 
 
Informed 
Consent
X 
 
 
 
 
Photographs 
X
X
X
X
Treatment
X
Treatment 
Discomfort/ 
Pain Evaluation
 
X 
 
 
 
Subject 
Questionnaires
 
X 
 
X 
X 
Clinician 
Questionnaires
 
X 
 
X 
X 
Adverse Events 
Assessment
 
X 
X 
X 
X 
 
*Screening and Pretreatment Procedures may occur at the same time as the first Treatment Visit. Must be performed at least 30 days prior to first 
treatment. 
**Pregnancy verification will only be required to be performed prior to each treatment if the treatment is on the abdomen.  

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2.14 Evaluation Methods 
Photographs: 
Photographs will be taken at all visits and will be used to assess safety and efficacy of treatment. 
 
Treatment Discomfort/Pain Evaluation: 
Subjects will be asked to report the general level of treatment discomfort on a scale of 0 (none) to 
10 (maximum intolerable pain) using the universal pain assessment tool (Appendix B) 
 
Subject Questionnaire:  
The subject will be asked their level of satisfaction using a 6-point Likert scale that ranges from 
“extremely satisfied” to “extremely unsatisfied.” 
 
Subject Satisfaction 
Rating 
Description 
6
Extremely Satisfied
5 
Satisfied 
4 
Slightly Satisfied 
3 
Slightly Unsatisfied 
2 
Dissatisfied 
1 
Extremely Unsatisfied 
 
Clinician Questionnaire:  
The Clinical Global Aesthetic Improvement Scale (CGAIS) ranging from “worse” to “very much 
improved” will be used to judge the improvement as seen by the treating Investigator. 
 
 
 
 
 
 
 
 
 
 
 
Blinded Evaluation: 
Three blinded independent reviewers will perform a photographic evaluation in which they will be 
asked to identify pre-treatment images when compared to post treatment images. The reviewers 
will be Board Certified Dermatologist and/or Surgeons and be chosen based on availability and 
have relevant clinical experience. They will attend a training session prior to grading.   
 
2.15 Adverse Event Recording 
All data captured must be supported by the Investigator’s timely assessment and documentation of 
the adverse event in the case report forms or source documents.  All documented adverse events 
Global Aesthetic Improvement Scale Assessment 
Rating
Description
1
Very Much Improved- Optimal cosmetic result in this subject 
2 
Much Improved- Marked improvement in appearance form the initial 
condition, but not completely optimal for this subject.   
3 
Improved- Obvious improvement in appearance from initial condition, but a 
re-treatment is indicated. 
4
No Change- The appearance is essentially the same as the original condition. 
5
Worse- The appearance is worse than the original condition. 

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will be reviewed by the Sponsor or designee to determine whether the adverse event meets 
regulatory reporting requirements and to ensure timely adverse event reporting to meet local and 
global regulatory requirements. All adverse events must be followed until their resolution. 
 
Adverse Events Pertaining to the Potenza™ Device: 
 Erythema (redness) may occur after the treatment, lasting a few hours and up to three days. 
 Tissue may be edematous (swollen) for a few hours up to several days. 
 Pinpoint bleeding on the surface of the skin can be expected with deeper treatments. 
Bleeding is temporary and is typically resolved by the end of the subject’s visit. 
 Overtreated tissue may heal with small areas of micro crusting or scabbing. 
 Burning sensation: subjects may feel uncomfortable temporarily while receiving treatment. 
 Temporary tingling which typically resolves within 48 hours. 
 
Other possible adverse effects may include pain/tenderness, folliculitis, skin burn, 
hypopigmentation, hyperpigmentation, infection, scarring, bruising, acne, dryness, eye twitching, 
eye tearing, petechiae, skin textural irregularity, and allergic reaction which may be transient and 
resolve over time. 
 
Adverse Events Pertaining to Neutral Pad: 
Mild heat or hot spots may be felt during treatment by the subject. If the subject reports heat at the 
pad site, evaluate the site, check for epidermal injury. Skins burns may occur if subject does not 
report if the pad becomes too hot.  
 
 
Adverse Events Pertaining to Anesthesia: 
Topical anesthesia, such as but not limited to; EMLA, LMX and Lidocaine/Tetracaine, will be used. 
The most common side effects for most anesthetics include redness, blanching, swelling and 
application site reaction.   
 
1% lidocaine (Lidocaine) with Epinephrine Injection: 
You may experience pain and numbness at the site of the injection. You may also experience redness, 
rash, infection, skin damage or nerve damage at the site of the injection. You may experience 
temporary loss of sensation and muscle function at the site of injection. 
 
Less common side effects include; large swellings that look like hives on the skin or in the mouth 
or throat. Pain, burning, paleness and altered temperature sensation. Subjects may be allergic to the 
contents of any anesthetic which may cause allergic-type reactions including anaphylactic symptoms 
and life-threatening or less severe asthmatic episodes in certain susceptible people.  
 
Adverse Events Pertaining to Nitronox: 
May experience nausea, vomiting, excessive sweating, euphoria, excitement, deep sedation, 
drowsiness, sleep, dizziness, lightheadedness, dysphoria, amnesia, and headaches. 
 
Adverse Events Pertaining to the Surgical Marker: 
Using surgical marker has minimal risks and may produce effects on the body such as redness or a 
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Other Cautions: 
Incomplete response or no response may occur since some subjects may not respond to treatment. 
 
2.16 Statistical Analysis 
 
2.16.1 Hypothesis 
For this study to be considered a success, the side effect profile is acceptable to the Investigator as 
it relates to this type of treatment.  
 
2.16.2 Sample Size Rationale 
Based on the need for the data collected from this study, it was determined that a total of 10 
patients would be required for the study, including departures.  
 
2.16.3 Patient Populations 
Interim results may be collected and reported.  All data will be analyzed at the end of the study.  
The primary analysis will be performed by the intention-to-treat approach.  Everyone who begins 
the treatment is part of the study whether he or she completes the study or not.  Additional per-
protocol analysis may also be performed on subjects who complete the entire clinical trial 
according to the protocol.  The most appropriate method of handling missing values will be chosen 
based on the individual trial goals, endpoints and context. 
 
The analysis of demographic, medical history, and efficacy variables will be based on all patients 
who are randomized and receive at least one treatment. The analysis of safety data will be based on 
all patients who are randomized, receive at least one treatment, and have at least some safety data.  
  
2.16.4 Analysis of Demographic and Medical History Variables 
Summaries will be prepared for all important demographic and medical history variables. For 
quantitative variables summaries will include the sample size, mean, median, standard deviation, 
minimum, and maximum.  For these variables the treatment groups will be compared using either 
a t-test or a Wilcoxon Rank Sum test, as appropriate.  For categorical variables the summaries will 
include the sample size and the number and percent of patients for each outcome.  For these 
variables the treatment groups will be compared using Fisher’s Exact test.  Statistical significance 
will be declared if the two-sided p-value is < 0.05.  
   
2.16.5 Analysis of Safety Variables 
Safety will be assessed through the degree of pain/discomfort related to the procedure (universal 
pain scale) and the collection of Adverse Events throughout the course of the study.  For each 
treatment group these variables will be summarized.  The summaries will include the number and 
percent of patients for each outcome.  No statistical comparisons will be performed for any of 
these variables. 
 
2.16.6 Analysis of Efficacy Variables 
The secondary outcome will be preliminary efficacy variable based on blinded evaluation of 
photographs from baseline to Visit 5 (1 month follow up) with respect to improvement of the 
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will be graded and the total and percentage of photos correctly identified will be compiled and 
analyzed.  Correct identification percentages will be calculated for each individual reviewer as 
well as a summary for all three reviewers.  Clinical success of grading will be declared if 80% 
independent reviewers achieve 80% correct identification of the photos. 
 
Other assessments will include physician grading with CGAIS evaluating baseline to visit 5 (1 
month post last treatment) with respect to the treated condition. The change from baseline to visit 5 
will be analyzed using a Mixed Model Repeated Measures Analysis of Variance.  A pairwise 
treatment group comparison at visit 5 will be performed using the results of this analysis.  If a 
patient has no post-baseline assessment of the primary efficacy variable the patient data will be 
excluded from the statistical analysis of the improvement.  Statistical significance with respect to 
the treatment group comparison at visit 5 will be declared if the two-sided p-value is <0.05. The 
change from baseline to visit 6 will also be analyzed. Subject satisfaction results from Visit 5 and 6 
will also be included in the summary.  The summaries will include the sample size, mean, median, 
standard deviation, minimum, and maximum.  Categorical variables will also include a summary 
which will include the number and percent of patients for each outcome.  The statistical 
significance of the mean change from baseline for each treatment group will be determined using a 
student’s paired t-test.   
 
3.0 
 RISK ANALYSIS AND MANAGEMENT  
3.1 Risk Determination 
This device study used in this study does not meet the FDA definition for a Significant Risk 
Device study per 21 CFR 812.3(m).  Therefore, the sponsor determines that this is a non-
significant risk device study. 
 
Significant risk device means an investigational device that: 
(1) Is intended as an implant and presents a potential for serious risk to the health, safety, or 
welfare of a subject; 
(2) Is purported or represented to be for a use in supporting or sustaining human life and presents a 
potential for serious risk to the health, safety, or welfare of a subject; 
(3) Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or 
otherwise preventing impairment of human health and presents a potential for serious risk to the 
health, safety, or welfare of a subject; or 
(4) Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject. 
 
3.2 Risk Management  
The Investigator in this clinical trial has been invited to participate based on his/her previous 
experience with the use of the system and/or similar systems and industry experience.  Experience 
with treatments is the most critical element in managing subject risk in this trial. 
 
In addition, as with any study, there is a risk of bias. Objective evaluation methods may be used in 
conjunction with subjective evaluation methods when feasible.  The value of the compensation to 
the clinical investigator for conducting the study is not influenced by the study outcome.  If 
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evaluators who did not partake in the study.  If information concerning investigator assessment of 
improvement or investigator satisfaction is collected, then it is not listed as an objective for the study. 
 
All other known risks will be disclosed to the subject via the informed consent process. Since this 
is an elective procedure and the subjects are volunteers, it can be assumed that their signature on 
the informed consent is indicative of their agreement to accept the risks involved. 
 
The risks to the subjects who participate in this study are the same as those for the subject 
undergoing similar ablative radiofrequency treatments. It is possible to have an adverse reaction to 
the Potenze™ device use. There may be some side effects that we don’t know about yet. 
 
3.3 Risk Analysis 
 
CONTEXT OF THE PROPOSED INVESTIGATION: 
Radiofrequency (RF) technology is commonly used in surgery, noninvasive treatments and 
aesthetic applications. RF technology combined with micro needling is a safe method for non-
ablative (A non-wounding device treatment which heats underlying skin) treatment because energy 
can be precisely delivered through the skin to the dermal tissue beneath with minimal injury to the 
epidermis.  
 
Aging skin shows decreased collagen synthesis and alteration of fiber networks. By gently heating 
dermis tissue (which is comprised of collagen, elastic fibers and ground substance), both 
immediate effects (collagen contraction) and long-term effects (wound-healing response with 
neocollagen production) will occur. RF-induced thermal injury to the dermal tissue will produce a 
microinflammatory response to induce collagen denaturation, contraction, and subsequent 
synthesis as well as elastin and ground substance production.iii Microneedling will cause discrete 
coagulative injury in the dermis while sparing the epidermis. This allows for a faster healing time 
and fewer complications in the treatment area. 
 
The extent of collagen shrinkage, fibroblast activation, fibroplasia and neocollagenesis in the 
different skin layers is based on a complex multivariate mechanism, which depends on the 
temperature distribution and timing.2 Further investigation of parameter optimization is necessary 
to achieve safe and efficacious results.   
 
ASSESSMENT OF RISKS OF THE PROPOSED INVESTIGATION: 
There are two risks identified with the Potenza™ device used in this study. The first risk identified 
is the safety profile of the device. The second risk identified is the efficacy of the treatment. There 
is a lack of clinical data for evidence of effectiveness when treating with the Potenza™ device. 
 
The risk identified with the overall clinical investigation is the integrity of the data collected. 
 
There are multiple clinical mitigation strategies for the risks identified. Proper training on the 
device and protocol will be performed. Data from other comparable devices, such as the Lutronic 
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treatment outcomes. Monitoring of the study will be implemented to minimize subject and data 
risks.  
 
ASSESSMENT OF BENEFITS OF THE PROPOSED INVESTIGATION:   
The subject may or may not have a reduction in the condition they present with. 
 
CONSIDERATION OF PATIENT PREFERENCE INFORMATION: 
Many physicians support the use of radiofrequency devices minimally invasive cosmetic 
treatments due to current patient satisfaction of cosmetic results with the currently available 
devices. However, there is still a level of interest in novel technologies that could reduce the need 
for future treatments.  
 
ASSESSMENT OF UNCERTAINTY: 
There is uncertainty of the safety and efficacy of parameters that are not recommended in the 
Potenza™ manuals.  
 
CONCLUSION: 
The Potenza™ device is intended for electrocoagulation and hemostasis of soft tissues for 
dermatologic conditions. This device is determined to be a non-significant risk study. The risks 
posed to the subjects and integrity of data are acceptable.  
 
Patient population to be enrolled in this clinical study:  
Total anticipated population: 10 Subjects 
Age Range years old: 18 – 60 Years Old 
Gender: Male or Female 
Condition: Brow lifting and or other conditions such as, but not limited to; Wrinkles, fine lines, 
crepey skin, acne scars, active acne, enlarged pores, stretch marks, or loose skin on the face, neck 
and/or body. 
 
4.0  
DEVICE DESCRIPTION AND SPECIFICATIONS 
The Potenza™ device was FDA cleared for use on February 20th, 2020 (K192545). The Potenza 
device is intended for use in dermatologic and general surgical procedures for electrocoagulation 
and hemostasis. 
 
This study is considered investigational because this device may not be used within its currently 
cleared instructions for use. 
 
The Potenza™ Device Specifications are: 
Input Rating 
100-240V, 50/60Hz, 500VA 
Applied Frequency 
1 & 2MHz 
Maximum Power 
MOTOR Handpiece  
Min1~Max50Watt, Rf Time=5~990ms, Output Voltage:0~100V(Load 
200Ω) 
AC Handpiece 
Min1-Max40Watt, Rf Time = 5~990ms, Output Voltage:0~80V(Load 
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The Potenza™ device Operator Manual: Attachment I 
 
The Potenza™ consumables are: Tips, NEM Pads 
 
5.0 
MONITORING PROCEDURES  
The Sponsor Standard Operating Procedure (SOP) for monitoring the investigative site will be 
followed. The sponsor will train the site following sponsor SOP’s and may be present at initiation 
of treatment.  The sponsor will also monitor the site periodically. The Investigator/Institution will 
permit trial-related monitoring, audits, IRB/IEC review, and regulatory inspections by providing 
direct access to source documents.  The sponsor may request intermediate data following each visit 
to evaluate treatment progress. Case Report Forms will be reviewed for current data and 
Regulatory Binders will also be reviewed for correct documents. The sponsor will collect data at 
the end of the follow up period. The sponsor will list the study on clinicaltrials.gov when required 
by FDA regulations.  
 
The monitoring plan for this study is outlined in the Cynosure Monitoring Plan.  
 
ASSIGNED CLINICAL RESEARCH MONITOR: 
Monitor #1 
Name: Kristy Luis  
Institution: Cynosure, LLC 
Address: 5 Carlisle Rd. Westford, Ma  
 
6.0  
LABELING  
Sample labeling will follow FDA regulations and the sponsor standard operating procedure.  
If applicable, the Potenza™ device label will include, (in accordance with 801.1):   
 
Statement: "CAUTION--Investigational device. Limited by Federal (or United States) law to 
investigational use."  
 
Additionally, the label or other labeling will describe all relevant contraindications, hazards, 
adverse effects, interfering substances or devices, warnings, and precautions. 
 
Directions for use are contained in the Potenza™ Operators Manual  
 
7.0  
CONSENT MATERIALS 
Forms and informational materials which are provided to the subject during the informed consent 
process are listed below: 
 
Form/Informational Material 
Description 
Pre and Post Treatment Instructions 

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Informed Consent Form 
 
 
8.0  
INSTITUTIONAL REVIEW BOARD INFORMATION 
This protocol, informed consent forms, and any amendments to the protocol will be reviewed by 
the appropriate Institutional Review Board prior to initiation.  The study will not be initiated 
without the approval from the Institutional Review Board.  
 
IRB Contact Information: 
IRB Name: Allendale Investigational Review Board 
IRB Chairperson: Robert Staab 
IRB Address: 30 Neck Rd. Old Lyme, CT 06371 
Phone: 860-434-5872 
Fax: 860-434-5892 
Email: Rta1ali1@aol.com 
 
9.0  
OTHER INSTITUTIONS  
If a part of the study is conducted by an institution that has not previously been identified within 
the Investigational plan each institution’s contact information will be documented below; 
 
No other institutions will be part of this study. 
 
 
10.0  ADDITIONAL RECORDS AND REPORTS  
If this is an IDE study, additional records and reports will be maintained on the investigation in 
addition to those prescribed in 21 CFR 812 sub-part G. If this is a non-IDE study, the study 
summary will be maintained on the investigation and may include those prescribed in 21 CFR 812 
sub-part G.   
 
Additional Records and Reports: 
Report    
Submit To   
Description/Constraints 
N/A 
N/A 
This is a non-IDE study; no additional records or 
reports will be maintained. 
 
 
11.0  PREGNANCY 
Females may not participate in this study if they are pregnant, breastfeeding, were pregnant within 
the last three months or are planning a pregnancy during the study.   
 

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If the subject thinks they have become pregnant during the study, it is important that they inform the 
Investigator immediately. If she becomes pregnant or thinks that she may be pregnant, she will be 
removed from the study and will be asked to perform a final evaluation similar to that of the final 
follow-up visit.  The Investigator may request to track the pregnancy and will report the pregnancy 
to the Sponsor. 
 
12.0      SUBJECT WITHDRAWAL  
The subject is free to withdraw from this study at any time. The subject must inform the Investigator 
immediately if they intend to withdraw. To terminate the subject’s participation in this study, they 
must contact the Investigator at the contact information listed on page one of the informed consent 
form. They will be asked to come to the study clinic or Investigators office to complete a final follow 
up visit and may be asked to perform end of study procedures.  Their decision to participate in this 
study or to withdraw from this study will not influence the availability of their future medical care and 
will involve no penalty or loss of benefits to which they are otherwise entitled. 
 
The Investigator in charge of the study can remove the subject from this study without their consent 
for any reason, including, but not limited to: 
a) His/her judgment that any condition or circumstance may jeopardize their welfare or the integrity 
of the study. 
b) Their failure to follow the instructions of the Investigator(s). 
c) If the study is stopped by the sponsor and/or Investigators participating in the study prior to 
completion. 
 
Data collected prior to withdrawal will be used in data analysis but after withdrawal no further data 
will be collected.  
 
13.0  PHOTOGRAPHY 
Standardized photographs will be taken of the treatment area. If the photograph is located on the 
face the subject will be asked to remove jewelry and make up and lotions prior to each photo session. 
Photographs will be taken with an appropriate high-resolution digital camera. Camera settings 
(lighting, distance, background, polarization, etc.) will be reproduced at each visit, so that 
photographs are suitable for comparison.  Photographs will be taken of the treatment area for study 
purposes.  If the subject does not wish to have their photographs taken, they cannot be in the study.  
 
14.0  ADVERSE REACTIONS DEFINITIONS AND REPORTING REQUIREMENTS 
All adverse events that occur, starting from the time of the first treatment, will be recorded in the 
source documents and Case Report Forms (CRF). 
Adverse Events (AE) occurring will be captured and followed until the condition resolves, 
stabilizes, is otherwise explained, or the subject is lost to follow-up. Subjects will be instructed that 
they may contact the Investigator at any time throughout the course of the study. 
The Investigator and/or designated study staff will review each event and assess its relationship to 
the study device (not related, unlikely, possible, probable, and highly probable). The following 
definitions will be used for rating relationship to the Potenza™ treatments:  

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 Not related – The event is clearly related to other factors such as the subject’s clinical state, 
therapeutic interventions, or concomitant medications administered to the subject. 
 Unlikely – The event was most likely produced by other factors such as the subject’s clinical 
state, therapeutic interventions, or a concomitant medication administered to the subject; and 
does not follow a known response pattern to the investigational product. 
 Possible – The event follows a reasonable temporal sequence from the time of investigational 
product administration; and/or follows a known response pattern to the study sampling 
sessions; but could have been produced by other factors such as the subject’s clinical state, 
therapeutic interventions, or concomitant medications administered to the subject. 
 Probable – The event follows a reasonable temporal sequence from the time of investigational 
product administration; and follows a known response pattern to the investigational product; 
and cannot be reasonably explained by other factors such as the subject’s clinical state, 
therapeutic interventions, or concomitant medications administered to the subject. 
 Highly Probable – The event follows a reasonable temporal sequence from the time of 
investigational product administration; and follows a known response pattern to the 
investigational product; and cannot be reasonably explained by other factors such as the 
subject’s clinical state, therapeutic interventions, or concomitant medications administered to 
the subject; and either occurs immediately following investigational product administration, or 
improves on stopping the investigational product, or reappears on repeat exposure, or there is a 
positive reaction at the application site. 
 
Each adverse event reported will be graded on a 3-point severity. Using the following 
definitions for rating severity will be used: 
 Mild – easily tolerated, causing minimal discomfort, and not interfering with normal everyday 
activities. 
 Moderate – sufficiently discomforting and may interfere with normal everyday activities. 
 Severe – incapacitating and/or preventing normal everyday activities. 
 
A Serious Adverse Event (SAE) is any adverse device experience that results in any of the 
following outcomes:  death, a life-threatening adverse device experience, in-patient hospitalization 
or prolongation of hospitalization, a persistent or significant disability/incapacity, or a congenital 
anomaly/birth defect. Important medical events that may or may not result in death, be life-
threatening, or require hospitalization may be considered a serious adverse device experience 
when, based upon appropriate medical judgment, they may jeopardize the subject or subject may 
require medical or surgical intervention to prevent one of the outcomes listed in this definition 
 
If any of the above adverse events are serious as defined by the FDA Code of Federal Regulations 
(CFR), Title 21, special procedures will be followed.  All serious adverse events will be reported 
within 24 hours of acknowledgment to the Sponsor whether or not the serious events are deemed 
sampling session related.  All serious event reporting will adhere to 21 CFR part 812 and the IRB 
will be notified accordingly.  
 
  
The SAE information will be entered into the database and a desk copy of the complete SAE 
report will be submitted to the study file.  

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Adverse events, whether serious or non-serious, will be followed until the condition is resolved, 
stabilized, otherwise explained or the subject is lost to follow-up.  Adverse events will be captured 
throughout the study and where appropriate, medical tests and examinations will be performed to 
document the resolution of event(s). Outcomes may be classified as resolved, improved, 
unchanged, worse, fatal, unknown or lost to follow-up.  Following the resolution of any study-
associated adverse events there will be no further adverse event reports for that subject. 
 
Reporting Adverse Events: 
Report    
Submit To   
Description/Constraints 
Adverse 
Events, 
Unanticipated 
Adverse 
Device 
Effect
 
IRB 
and 
Sponsor 
If an unforeseen complication is determined to be 
an unanticipated adverse device effect, the 
investigator’s report must be submitted within 10 
working days after the investigator first learns of 
the effect. 
Serious 
Adverse 
Events 
IRB 
and 
Sponsor 
The sponsor must be notified within 24 hours of 
serious adverse events. The IRB must be notified 
within 10 working days of serious adverse events 
as defined by FDA guidelines.  
 
 
15.0  PROTOCOL DEVIATIONS 
All requests for protocol deviations by the Investigator have to be communicated to the sponsor in 
writing and if accepted by the Sponsor must be approved by the IRB.  If a deviation occurs, the 
Investigator must inform the Sponsor as soon as possible.  The Sponsor will notify the IRB in 
accordance with IRB specific policies. 
 
 
16.0  CONFIDENTIALITY AND DISCLOSURE OF MEDICAL INFORMATION 
As part of this study the Investigator and the team at the research facility will keep records of subject 
participation in the study.  These study records will include personal information that the subjects 
provide including age, sex, etc., the results of the study, information about response to treatments, 
photographs taken during the study and other medical information relating to participation in the 
study.   
 
Under federal law the study records cannot be used or disclosed by the Investigator for research 
purposes unless subjects sign the informed consent authorization. 
 
Some or all of the test results, photographs and other information will be reported to Cynosure, Inc. 
the manufacturer of the test device (Sponsor), and consultants that are helping conduct the study.  
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report them to the U.S. Food Administration and the FDA, Institutional Review Board or other 
regulatory agencies in the United States and/or foreign countries.  The subject’s study records will 
be assigned a code number by the study team and they will ordinarily not be identified by name in 
the study records that are sent to the Sponsor and its consultants.  However, The Sponsor, the 
Institutional Review Board and its consultants will have the right to see the complete study records, 
including the subject’s name, and might choose to do so.  If reports or articles are written about the 
study, the subject will not be identified by name in them however your study information and 
photographs may be used. 
 
The research facility will review and use the study records only for purposes of this study.  They 
will keep the subject’s identity confidential and, except for the disclosures described above, will not 
disclose the study records to other parties unless disclosure is required by law.  Once the research 
facility discloses information in the study records, photographs or medical records to the Sponsor or 
its consultants, the information will no longer be protected by federal law.  Because of the need to 
release information to these parties, absolute confidentiality cannot be guaranteed.  However, the 
Sponsor and its consultants will only use information for purposes of the study and will not disclose 
your study records to parties other than; the FDA or other regulatory agencies in the United States 
and/or foreign countries, unless disclosure is required by law.  If reports or articles are written about 
the study, subjects will not be identified by name in them however, subject study information and 
photographs may be used. 
 
Study records will be kept at the research facility according to applicable regulations and policies 
and may be kept indefinitely following the completion of the study. Subjects will not have the right 
to review their records while the research is in progress.  However, they will be able to review their 
records after the research has been completed. 
 
17.0  CLINICAL RESEARCH CONDUCT 
The study will be conducted in accordance with the protocol, International Conference on 
Harmonization (ICH) GCP guidelines, applicable regulations and guidelines governing clinical 
study conduct and ethical principles that have their origin in the Declaration of Helsinki.  The 
investigator must ensure that the study is conducted in accordance with the provisions as stated in 
the FDA regulations and complies with the applicable local or regional regulatory requirements. 
 
18.0  REPORTING FOR THE STUDY 
A study summary report will be generated.  It will include a description of the clinical conduct of 
the study and results. 
 
Study Summary Reporting:                     
 
Report 
Submit To 
Description/Constraints 
Deviation 
from 
Investigational 
Plan 
IRB 
and 
Sponsor 
A deviation performed in an emergency to protect 
the life or physical well-being of a patient 
necessitates notification of the IRB and sponsor. 
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5 working days after the emergency occurred. 
Deviations in a non-emergency situation require 
notification to sponsor prior to implementation 
Failure to 
Obtain 
Informed 
Consent 
 
IRB 
and 
Sponsor 
 
 
The Investigator must make notification within 5 
working days after device use, using the Protocol 
Deviation CRF. The report must include a brief 
description of the circumstances justifying the 
failure to obtain informed consent. 
Final Report 
IRB 
and 
Sponsor
The Investigator must submit a final report within 3 
months after termination or completion of the 
investigation.
Withdrawal of 
IRB approval 
Sponsor 
 
The Investigator must report a withdrawal of the 
reviewing IRB approval within 5 working days. 
Progress 
Report 
IRB, Monitor 
and 
Sponsor
The Investigator must submit progress reports at 
regular intervals, and as required by the IRB, but in 
no event less than annually.
 
 
19.0  DISCLOSURE 
The Principal Investigator and Cynosure employees and consultants have signed confidentiality 
agreements with the sponsor.  This confidentiality agreement ensures that all information provided 
to the Investigator or Data Management and Statistics group dealing with the study and information 
obtained during the course of the study will be regarded as confidential. 
 
20.0  RESPONSIBILITY OF THE INVESTIGATOR 
The Investigator is responsible for ensuring that the clinical study is performed in accordance with 
the International Conference on Harmonization (ICH), Good Clinical Practice (GCP) guidance E6, 
FDA Good Clinical Practice Regulations, Declaration of Helsinki (DoH) and the Health Human 
Service (HHS) Belmont Study. Investigators will supply information to the sponsor such that the 
sponsor can comply with the Financial Disclosure Rules. 
 
21.0  PROCEDURE FOR AMMENDMENTS TO PROTOCOL 
No deviations from this protocol will be permitted, except in a medical emergency, without the 
approval of the Sponsor.  Any amendment to this study will be discussed by the Investigator and the 
Sponsor.  If agreement is reached concerning the need for modification, this will be made in a formal 
amendment to the protocol. 
 
All revisions and/or amendments to the protocol must be approved in writing by the appropriate 
Institutional Review Board. 
 

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22.0  TERMINATION OF STUDY 
The Sponsor reserves the right to discontinue this study for administrative reasons at any time.  The 
Investigator reserves the right to discontinue the study for safety reasons at any time in collaboration 
with the Sponsor. 
 
23.0  DATA SECURITY 
To ensure the privacy and confidentiality of data for this protocol, the data will be stored on a 
restricted access location on a company server. Access to the project directory containing the data 
will be limited to the Investigators and research staff.  Information about data security awareness is 
promoted through user training and education, supplemented by policies and procedures. Password 
protection will be used for all transactions that allow viewing, editing, and analysis of data, or that 
provide access to data fields derived from the original source documents. 
 
24.0  REPORT OF PRIOR INVESTIGATIONS 
 
The report of prior investigations or predicates are: 
 
Protocol 
Device 
IRB Name 
Determination 
Initial IRB 
Approval Date 
CYN19-RF-MN-01 
Potenza 
AIRB 
Meets the criteria for exemption 
from IDE regulations, non-
significant risk 
7/11/2019 
 
 
 

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APPENDIX A: 
Protocol Revisions Tracker 
 
Version 
Date 
Editor 
Description 
October 23, 2020 
Kristy Luis 
IRB Submission 
February 2, 2021 
Kristy Luis 
Reduced number of treatments to 3 from 5. 
Other administrative changes.  
 
 
 
 
 
 
 
 
 

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APPENDIX B: 
 
 

PROTOCOL #: CYN20-RF-MN-PROFILES 
 
 
 
   
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Version 2.0: February 2, 2021 
CONFIDENTIAL 
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REFERENCES 
 
1 Sherber, N. S., MD FAAD. (2018). The Millennial Mindset. Journal of Drugs in Dermatology, 17(12), 
1340-1342. 
2 Elsaie, M. (2009). Cutaneous Remodeling and Photorejuvenation Using Radiofrequency Devices. Indian 
Journal of Dermatology, 54(3), 201. doi:10.4103/0019-5154.55625 
iii Levy, Adam S. et al. (2016). Radiofrequency Physics for Minimally Invasive Aesthetic Surgery. Clinics 
in Plastic Surgery, 43(3), 551 – 556. doi: https://doi.org/10.1016/j.cps.2016.03.013