Post Market Study To Collect Efficacy Data For The Treatment Of Wrinkles With A Radiofrequency Device
Phase: NA
Conditions: Wrinkle, Benign Pigmented Lesions, Benign Vascular Lesions
Sponsor: Cynosure, Inc.

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NCT:05096247 
POST MARKET STUDY TO COLLECT EFFICACY DATA FOR THE TREATMENT OF 
WRINKLES WITH A RADIOFREQUENCY DEVICE 
UNIQUE PROTOCOL ID: 7027-PM01-2021 
 
Document Date: January 20, 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
INVESTIGATIONAL PLAN 
 
PROTOCOL #: 7027-PM01-2021 
 

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POST MARKET STUDY TO COLLECT EFFICACY DATA FOR THE TREATMENT OF 
WRINKLES WITH A RADIOFREQUENCY 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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POST MARKET STUDY TO COLLECT EFFICACY DATA FOR THE TREATMENT OF WRINKLES WITH A 
RADIOFREQUENCY 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: 
Edward Jaccoma , M.D. 
Excellent Vision 
155 Griffin Road 
Portsmouth, NH 03801 
Phone: 603-430-5225 
Email: ejaccoma@aol.com 
 
SITE #2 CONTACT INFORMATION: 
Principal Investigator Information: 
Raminder Saluja, M.D. 
Saluja Cosmetic and Laser Center 
9615 Northcross Center Court, Suite B 
Huntersville, NC 28078 
Phone: 704-584-4071  
Email: msaluja21@hotmail.com 
 
SITE #3 CONTACT INFORMATION: 
Principal Investigator Information: 
Sean Doherty, M.D. 
5 Carlisle Rd 
Westford, MA 01886 
Phone: 617-735-8735 
Email: info@seandohertymd.com 
 
Sub-Investigator: 
Felicia Whitney, RN 
 
 
SPONSOR CONTACT INFORMATION: 
Jennifer Civiok 
Director, Clinical Development  
5 Carlisle Road 
Westford, MA 01886 
Phone: 978-399-4343 
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 
 
 

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ATTACHMENTS/REFERENCES 
I. 
Operator Manual for the TempSure device  
II. 
Clinical Reference Guide for the TempSure device  
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 TempSure device. The study will be using the Mini Envi 
handpiece and may also use the Envi handpieces and Icon device (Max series).  
 
The intended use of the TempSure device used in this study to assess the efficacy of the handpiece 
for the treatment of facial wrinkles. If the Icon device is used, the intended use will be for the 
treatment of benign pigmented and/or vascular lesions. 
 
1.2 Objectives   
1. Primary Objective:  
• Photographic evaluation with correct identification of pre-treatment 2D images 
when compared to the 12 week follow up images performed by three independent 
reviewers. 
2. Assessments: 
• Photographic evaluation with correct identification of pre-treatment 2D images 
when compared to the 4 week follow up images performed by three independent 
reviewers. 
• Photographic evaluation with Fitzpatrick Wrinkle Severity Scale (FWSS) grading 
comparing pre-treatment images to the 4 and 12 week follow up images performed 
by three independent reviewers. 
• Principle Investigator assessment using the Global Aesthetic Improvement Scale 
(PGAIS) at the 4 and 12 week follow up visit. 
• Subject assessment using the Global Aesthetic Improvement Scale (SGAIS) at the 4 
and 12 week follow up visit. 
• Subject Questionnaires 
o Pre-Treatment 1  
o Post Treatment 1 
o Follow Up 
3. Safety Objectives: 
• Collection of Adverse Events 
• Collection of Treatment Discomfort/Pain Evaluation 
 
 
1.3 Duration of the Investigation 
The sponsor anticipates that all subjects can be enrolled within 3 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 12 months. 
 
2.0 
PROTOCOL 
2.1 Protocol Methodology and Analysis 
Methodology: 
Subjects are to be enrolled in this clinical study if they are a healthy male or female 18 years of age 
or older. Up to 50 subjects will be enrolled at 3 study centers. Subjects will be enrolled into 2 

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groups, Group A for TempSure treatments only and Group B for TempSure and Icon treatments. 
Randomization will not be required as subjects will only be enrolled in Group B and treated with 
the Icon device if they present with pigment and/r vascular lesions. Subjects will attend a 
screening/pretreatment visit which may be performed on the same day as the treatment visit. 
Subjects in Group A will receive up to 4 treatments with the TempSure device on the face. 
Subjects in Group B will receive 2 treatments with just the TempSure device and 2 treatments with 
both the TempSure and Icon device. Some subjects may be asked to return for an optional 5th 
treatment (2 – 3 weeks post last treatment) with the Icon device (and/or TempSure device) after the 
completion of their 4 treatments at the discretion of the Investigator. Subjects may receive a phone 
call 1 week (1-7 days) after each treatment to record side effects. Subjects will return for follow up 
visits at 4 and 12 weeks post last treatment for efficacy and side effects assessments. 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. 
 
 
 
Analysis: 
Upcoming generations are proving to have an interest in non-ablative aesthetic 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 technology for the treatment 
facial wrinkles and skin laxity needs to be further investigated to optimize treatment parameters for 
safe and effective non-ablative aesthetic treatments.  
 
Relevance: 
Over time, skin structure degrades due to a variety of internal and external conditions. As enzymes 
break down collagen and elastin, skin loses its suppleness and becomes loose.  UV exposure, diet, 
and smoking among other behaviors all contribute to the skin becoming lax.  Body wrinkles, 
particularly on the abdomen, are a sign of aging and are also a prevalent concern with postpartum 
women or subjects who have lost weight. It is estimated that adult skin loses approximately 1% of 
its dermal collagen content on an annual basis due to increased collagen degradation and decreased 
collagen synthesis.2 Radiofrequency, ultrasound, non-ablative fractional technology, and ablative 
technology have all been used to varying degrees of success.  The limitations of current products 
on the market include different side effect profiles and modes of administration. 
 
Testability: 
The TempSure device is currently cleared for use for non-ablative treatment of mild to moderate 
facial wrinkles and rhytids (K171262). The Icon device is currently cleared for used for the Max 
Series Intense Pulsed Light Handpieces for the treatment of benign pigmented epidermal 
and cutaneous lesions, including warts, scars and striae; removal of unwanted hair from 
skin types 1-VI, and to effect stable long-term, or permanent, hair reduction; treatment 
of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and 
treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, 
telangiectasias, rosacea, facial and leg veins (K103664). This study will utilize the collection of 
data and imaging to support current and additional marketing claims. 
 
Compatibility: 

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In earlier stages of facial wrinkles and skin laxity, and therefore younger subjects, there is 
normally minimal appearance of those conditions, allowing for less aggressive and therefore safer 
overall treatments. Younger subject’s bodies are also capable of responding to the treatment 
quicker due to their ability to produce more collagen quicker than an older subject. As a subject 
gets older their condition becoming more severe, this may result in the subject needing more 
overall treatment and more aggressive treatments to get their body to respond the same way that a 
younger subject may be able to respond.   
 
Predictive power: 
While this study will observe the efficacy of the device on the face, this treatment could potentially 
be applied to a variety of body areas and other potential applications. Assuming there an 
acceptable safety profile, it would be appropriate to expect results in different areas. 
 
2.2 Protocol Study Design 
This is a prospective, open label, multi-center clinical study to collect efficacy data on the 
TempSure device and may also collect data on the Icon device. 
 
2.3 Subject Selection Criteria 
 
Subjects will meet the criteria described below: 
 
Inclusion Criteria: 
• A healthy male or female 18 years of age or older. 
• Agrees to be treated with the TempSure device. 
• 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 has a cut, wound, or infected skin on the area to be treated.  
• The subject is on local, oral, or systemic anesthetic agents.  
• The subject has nerve insensitivity to heat in the treatment area.  
• 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 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 6 months (or at the discretion of the Investigator) prior to entering this study.  

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• The subject has any embedded electronic device that gives or receives a signal, the device 
should be turned off or removed prior to treatment. 
• The subject has an embedded pacemaker or implantable cardioverter defibrillator (ICD), 
the client’s cardiologist must be consulted prior to treatment. 
NOTE: This device has not been tested on patients implanted with electronic devices that 
receive or emit signals, such as: Pacemakers, Implantable Cardiac Defibrillators (ICD), or 
Cardiac Resynchronization Therapy (CRT) devices. 
• If the neutral pad would need to be placed on a subject that has a metal plate, rod, or any 
metal implant that could conduct heat from the Smart Handpiece or surgical handpiece. 
• The subject is allergic to adhesives, such as glues on medical tape, they should be alerted 
that a rash may occur on the neutral pad site and an over the counter solution may be used 
to treat the area. 
• The subject is allergic to gold, such as the metallic covering of the TempSure handpieces. 
• The subject is allergic to corn, such as the corn derivative ingredient in Parker Aquasonic 
Gel. 
• If the subject has an unhealthy expectation of the results – this is not plastic surgery and all 
subject should be fully informed of the treatment’s expected results.  
• 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. 
• Studies of the use of the RF generator on subjects that have any of the following conditions 
is unknown: 
o Autoimmune Disease 
o Diabetic  
o Herpes Simplex 
• Use caution when treating areas that have scars, tattoos, permanent makeup, and permanent 
brows. 
 
Exclusion Criteria for Icon Treatments Only: 
• The subject is using systemic steroids (e.g. prednisone, dexamethasone) prior to or during 
the course of treatment. 
• The subject has a medical condition or is receiving treatment that significantly compromise 
healing response. 
• The subject has a history of light-induced seizures. 
• The subject has a history of skin photosensitivity disorders. 
• The subject has a history of hypertrophic scars or keloid formation. 
• The subject has a history of radiation therapy in area to be treated. 
 
Additional Cautionary Criteria for Icon Treatments Only: 
• The subject is not allergic to medications, latex or other substances that may be used during 
treatment course. 
• The subject’s skin type is appropriate for the handpiece to be used. 
• The subject is taking photosensitizing medication. Perform test spots 24 hours up to one 
week before considering treatment. 

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• The subject is currently taking blood thinning medications or anti-coagulants. The subject 
should discontinue the use of these medications if determined to be safe to do so by their 
prescribing physician. With the prescribing physician’s approval, the subject should stop 
taking the medication at least 2 weeks prior to and throughout the treatment course. 
• The subject has a condition or is taking medications that alters the ability of the blood to 
coagulate. 
• The subject is currently using Tretinoin and topical retinoids, e.g., Retin-A®, Renova® and 
exfoliating products. Although use in the area to be treated is not absolutely 
contraindicated, it is known to make skin more sensitive and prone to exfoliation. 
Candidates for Icon™ treatment should be advised to discontinue the use of exfoliating 
creams and other exfoliating products two (2) weeks prior to and during the entire 
treatment course. 
• The subject has a history of heat urticaria. They may develop hives with exposure to light 
pulses. 
• The subject has Herpes I or II within the treatment area. Before a treatment, candidates 
should consult their primary care physician for medical evaluation and possible prophylaxis 
to minimize the chance of a herpetic breakout. A small percentage of persons may 
experience an activation of oral herpes simplex virus infection within 5-10days after the 
procedure, even with appropriate prophylaxis. 
• The subject has received Botulinums treatments in the treatment area. There is the 
possibility for increased diffusion of Botulinums, such as Botox®, as a result of edema 
associated with facial light-based treatment, which may result in facial asymmetry when 
these procedures are performed at the same visit. Many physicians recommend waiting for 
a minimum of 2 weeks after a Botox injection before performing facial light-based 
treatments. Cynosure has conducted no clinical trials and cannot recommend any specific 
waiting time. 
• The subject has Pigmented Lesions in treatment area. If treating over a pigmented lesion, 
the lesion must be diagnosed as benign by a qualified practitioner prior to treatment. 
Inaccurate diagnosis and inadvertent treatment of a skin cancer may lead to a delay in the 
person receiving proper medical care. 
• Th subject has Cosmetic Dermal Fillers/Implants in treatment area. This Handpiece has not 
been evaluated or tested on areas with cosmetic dermal fillers, neurotoxins, or implants. 
• The subject has had unprotected sun exposure or use of tanning beds or creams in areas to 
be treated. Protected sun exposure means wearing protective clothing and the daily use of a 
SPF-45 or greater sunscreen. Those being treated should be advised to discontinue indoor 
and outdoor tanning at least four (4) weeks prior to treatment, during the treatment course, 
and four to six (4 to 6) weeks after treatment. This will reduce the chance of skin color 
changes and manifestation of new pigmented lesions. 
• The subject has a history of Menstrual dysfunction/Polycystic Ovarian Syndrome (PCOS). 
Those with menstrual dysfunction, such as PCOS and/or ovarian hyperandrogenism, may 
have unpredictable results. These subjects tend to have hirsutism secondary to their disease 
and should consult a primary care physician before a light-based treatment. 
• The subject has a history of vitiligo, eczema, psoriasis, allergic dermatitis, any diseases 
affecting collagen including Ehlers-Danlos syndrome, and scleroderma may affect response 
to treatment. 

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• The subject is of Middle Eastern and Mediterranean descent. They may have an ill-defined 
hair line with no obvious transition of the hairline to the face which may put them at risk of 
paradoxical hair growth. These clients are at a high risk for hair stimulation and should be 
advised of this phenomenon before treating. 
 
Be sure to list all concomitant medications taken or procedures performed before, during and after 
the trial  
 
Subjects will be recruited for the study through the existing patient database and may also be 
recruited through 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 be participating 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 will 
be discussed, and 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 form and their involvement in the study. Subjects will be informed of site’s 
COVID-19 procedures that adhere to federal and state guidelines at this time. Subjects who sign 
the informed 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.  
 

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2.6 Pre-Treatment Procedures 
If the subject is of childbearing potential (i.e. females not post-menopausal or not surgically 
sterile), they will be asked if they are pregnant, the date of their last menstrual cycle, and perform a 
urine pregnancy test at the site prior to their first treatment. Pregnancy verification will be 
performed by verifying the date of their last menstrual cycle at each subsequent treatment. A urine 
pregnancy test may also be conducted at the Investigator’s discretion at any time 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.  
 
• Photographs will be taken prior to the first treatment and may be taken prior to each 
subsequent treatment.  
• The following Pre-Treatment instructions will be reviewed: 
o Shave any visible hair on the area to be treated.  
o Do not wear constrictive clothing. Your back must be accessible for the neutral pad to be 
attached.    
o The treatment area must be free of any open lesions or infections.  
o For an optimum treatment, keep hydrated by drinking water (at least 8 cups daily) or 
hydrating fluids, such as Gatorade, and avoid drinking alcohol for 24 hours in advance. 
 
2.7 Treatment Procedures 
• Prior to treatment 1 only, subjects will be asked to complete a Pre-Treatment 1 Questionnaire. 
• The defined study area will be identified and may be marked with a surgical marker. 
• Procedures for the TempSure treatment: 
o A neutral pad will be placed on the back in an area determined by the Investigator to 
maintain standard energy settings and to require less power from the device during the 
treatment.  
o The subject may be required to wear eye shields at the discretion of the Investigator. 
o Gel will be applied to the treatment area.  
o The handpiece will be placed in contact with the skin. 
o The entire defined treatment area will then be treated by delivering energy to the skin. 
o Temperature will be continuously monitored and recorded during treatment.  
• Procedures for the Icon treatment: 
o All operators and subjects will wear appropriate protective eyeglasses during the pulse-
light treatments. 
o The Skintel Melanin Reader may be used for objective measurement of the melanin 
content of skin. The Skintel Reader may provide guidance to help select test spot 
settings. 
o Test spots will be performed prior to treatment in an area in or close to the treatment 
area in order to determine safe parameters for treatment.  
o The handpiece will be placed in contact with the skin.  
o The entire defined treatment area will then be treated by delivering adjacent pulses with 
minimal overlap of 20% or less.  

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o An air-cooling system may be used during treatment. The air-cooling system allows for 
the continuous flow of cold air on the treatment area to ease the sensation from the 
pulse. 
• Parameters may be adjusted throughout the treatment to increase subject comfort. 
• 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. 
• The additional treatments will follow the same procedure. 
• Subjects will receive up to 4 treatments on the face. Subjects in group B may be asked to return 
for an optional 5th treatment with the Icon device (and/or TempSure device) at the discretion of 
the Investigator.  
 
2.8 Post Treatment Procedures 
• Adverse events will be documented after treatment. 
• Photographs may be taken post treatment.  
• After treatment 1 only, subjects will be asked to complete a Post Treatment 1 Questionnaire. 
• The following post treatment instructions will be reviewed:  
o If the skin is slightly pink or red in areas following the treatment, avoid hot water when 
washing or showering until any erythema (redness) has subsided.  
o Soothing creams or moisturizers, such as Aveeno, may be used.  
o Gently massage the treated area daily for 5 minutes for the duration of your 
involvement in the study. 
o Use a sun block with UVA and UVB protection with SPF of 30 or greater to prevent 
sun damage.  
o Maintain the same weight and exercise routine throughout the study. 
• If the subject is treated with the Icon device, the following post treatment instructions will also 
be reviewed: 
o  A mild sunburn-like sensation is expected. This usually lasts two to twenty-four (2-24) 
hours but can persist up to seventy-two (72) hours. Mild swelling and/or redness may 
accompany this, but it usually resolves in two to three (2-3) days. Apply wrapped ice or 
gel packs to the treatment area for ten to fifteen (10-15) minutes every hour for the next 
four hours, as needed. Never apply ice directly to skin. An oral, over-the-counter anti-
inflammatory (ibuprofen such as Advil®) or an analgesic (acetaminophen such as such 
as Tylenol®) may be taken to reduce discomfort. Use medicine according to 
manufacturer’s recommendations. 
o Until redness has resolved, it is recommended to avoid the following: 
o Applying cosmetics to treated areas. 
o Swimming, especially in pools with chemicals, such as chlorine. 
o Hot tubs, Jacuzzis, and saunas. 
o Activities that cause excessive perspiration or any activity that may raise core 
body temperature. 
o Sun exposure and tanning in treated areas. Apply a SPF 45 or greater sunscreen 
to prevent skin color changes. 
o Aggressive scrubbing and use of exfoliants on the treated area. 
o Bathe or shower as usual. Treated areas may be temperature-sensitive. 

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o Pigmented lesions may initially look raised and/or darker with a reddened perimeter. 
o Pigmented lesions will gradually turn darker over the next twenty-four to forty-eight 
(24-48) hours. It may turn dark brown or even black. 
o Pigmented lesions will progress to darkening and/or crusting and will start flaking off 
in an average of seven to twenty-one (7-21) days. 
o Vascular lesions may undergo immediate graying or blanching, or they may exhibit a 
slight purple or red color change. The vessels will fully or partially fade in about ten to 
fourteen (10-14) days.  
o Do not pick or pull at darkened lesions as scarring may occur. 
 
2.9 Follow Up 
• Subjects may receive a phone call 1 week (1-7 days) after each treatment to record side effects. 
• Subjects will return for follow up visits at 4 and 12 weeks post last treatment. 
• Photographs will be taken, adverse events will be documented, and subject questionnaires will 
be performed at all follow up visits.  
• Any subject affected by COVID-19 that is not able to attend their follow up visits to complete 
the study will be asked to return to the site for a final follow up visit within 1 year of last 
treatment.  
• 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. 
 
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 - 5 
Treatment 
Visit*** 
(Optional) 
Call 
(Optional) 
Visit #6 
Visit #7 
Procedure 
Screening and 
Pretreatment 
Procedures 
Treatment 
Visits 1-4 
(1 - 2 weeks 
apart) 
Treatment 
Visit #5 
(2 - 3 weeks post
last treatment) 
Phone Call  
1 Week 
Post Each Tx 
(1-7 Days) 
Follow Up 
4 Weeks 
Post Last Tx 
(+/- 1 Week) 
Follow Up 
12 Weeks 
Post Last Tx 
(+/- 1 Week) 
Medical History 
X 
 
 
 
 
 
Pregnancy Verification** 
X 
X 
X 
 
 
 
Informed Consent 
X 
 
 
 
 
 
Photographs  
X 
X 
X 
 
X 
X 
FWSS 
X 
 
 
 
X 
X 
Subject Pre-Treatment 1 
Questionnaire 
 
X 
 
 
 
 
Treatment 
 
X 
X 
 
 
 
Treatment Discomfort/ 
Pain Evaluation 
 
X 
X 
 
 
 
Subject Post Treatment 1 
Questionnaire 
 
X 
 
 
 
 
PGAIS 
 
 
 
 
X 
X 
SGAIS 
 
 
 
 
X 
X 
Subject Follow Up 
Questionnaire 
 
 
 
 
X 
X 
Adverse Events 
Assessment 
X 
X 
X 
X 
X 
X 
*Screening and Pretreatment Procedures may occur at the same time as the first Treatment Visit. 
**Pregnancy verification required before each treatment only for women of childbearing potential.  
***Group B only

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2.13 Evaluation Methods 
Photographs: 
Photographs will be taken at baseline and at the 4 and 12 week follow up visit, and may be taken at 
eat treatment visit to assess the efficacy and safety 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) 
 
Fitzpatrick Wrinkle Severity Scale 
The Fitzpatrick Wrinkle Severity Scale will be used to evaluate outcomes. Live evaluation will be 
performed at Baseline and the 4 and 12 week follow up visits. The results will be compared to 
determine improvement.   
 
 
 
Subject Treatment Questionnaire: 
Subject treatment questionnaires may be collected from each subject to obtain feedback on their 
treatment experience.  
 
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 Dermatologists and/or Surgeons and will be chosen based on availability 
and have relevant clinical experience. They will attend a training session prior to grading.   
 
Physician and Subject Questionnaire:  
The Global Aesthetic Improvement Scale (GAIS) ranging from “worse” to “very much improved” 
will be used to judge the improvement as seen by the subject and Investigator. 
Global Aesthetic Improvement Scale Assessment 
Rating 
Description 
1 
Very Much Improved- Optimal cosmetic result in this subject 

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2.14 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 
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 TempSure Device: 
Mild discomfort during treatment may be experienced by the subject. Typically, the discomfort is 
temporary and localized within the treatment area. Mild edema (swelling) and erythema (redness) 
may occur. Initial studies indicate that these side effects typically resolve within 2 to 24 hours. 
 
Other anticipated side effects may include; pain, skin burns, bleeding, scarring, crusting, bruising, 
infection, itching, prolonged edema (swelling) and erythema (redness), hardness, and nodules. Loss 
of hair pigment may also occur within and adjacent to the treatment area. 
 
Adverse Events Pertaining to the Icon Device:  
Adverse effects can include discomfort/pain, redness, swelling, pinpoint bleeding, skin peeling, 
itching, scabbing, crusting, purpura, and bruising, which are usually transient and resolve without 
intervention. 
 
Possible adverse effects include pustules (such as ingrown hairs), skin burns, hypopigmentation, 
hyperpigmentation, removal or lightening of freckles, scarring, infection and allergic reaction 
(such as a rash). There is also risk of incidental hair reduction or removal in the treated areas. 
 
People of Middle Eastern and Mediterranean descent and those who have an ill-defined hair line 
with no obvious transition of the hairline to the face are at a high risk for hair stimulation 
(paradoxical hair growth). 
 
Adverse Events Pertaining to Gel: 
The gel is a water-based gel that may be placed on the skin during the TempSure® treatment. No 
known adverse events are documented. However, an allergic reaction is always possible when 
placing a topical gel onto the skin. Allergic reaction may include a mild reaction such as skin redness, 
irritation, or hives. 
 
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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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 Cooling: 
Anticipated transient side effects associated with forced air/contact cooling may include tingling, 
itching, decreased sensation, numbness, redness and pain. 
 
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 
rash. Markings may remain visible for a few days or may be removed with alcohol. 
 
Other Cautions: 
Incomplete response or no response may occur since some subjects may not respond to treatment. 
 
2.15 Statistical Analysis 
 
2.15.1 Hypothesis 
For this study to be considered a success, of pre-treatment images when compared to post 
treatment (90 day) images will be ≥80%. 
 
For the additional assessments to be considered a success, the following must be true: 
 
• 
In cases where the subject’s improvement is being graded on a scale, such as the FWSS and 
GAIS scale, we will test the statistical significance of our results against a hypothetical 
population that would have no change (average score of 4). 
• 
Subject treatment and clinician usability questionnaires are collected. 
• 
The side effect profile (adverse events) and the average pain score is acceptable to the 
Physician as it relates to the type of treatment. 
 
2.15.2 Sample Size Rationale 
Based on the need for data collected from this study, it was determined that a total of 50 subjects 
will be required, including departures. 
  
2.15.3 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.  

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2.15.4 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.  
  
2.15.5 Analysis of Efficacy Variables 
Additional efficacy variable is the change from baseline to Visit 7 (12 week follow up visit). 
Baseline is defined as the last assessment prior to the first treatment. The change from baseline to 
visits 6 and 7 will be analyzed using a Mixed Model Repeated Measures Analysis of Variance.  A 
pairwise treatment group comparison at visit 7 will be performed using the results of this analysis.  
If a patient has no post-baseline assessment of the primary efficacy variable it will be assumed that 
the change from baseline to visit 7 is zero.  The changes to visits 6 and 7 will be left as missing.  
Statistical significance with respect to the treatment group comparison at visit 7 will be declared if 
the two-sided p-value is < 0.05.  For each treatment group, summaries will be prepared for both the 
observed assessment and the change from baseline.  The summaries will include the sample size, 
mean, median, standard deviation, minimum, and maximum.  The statistical significance of the 
mean change from baseline for each treatment group will be determined using a paired t-test. 
 
2.15.6 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. 
 
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. 
 

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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 
photographic results are listed as the primary objective, they are to be evaluated by blinded 
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 non-ablative radiofrequency treatment. It is possible to have an adverse 
reaction to the TempSure 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 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 without damaging 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.3 This, in turn, creates a tightening 
effect that helps to eliminate facial wrinkles, and is also used for other cosmetic treatments on the 
body.4 
 
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: 

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The risk identified with the overall clinical investigation is the integrity of the data collected. There 
are multiple clinical mitigation strategies for the risk identified. Proper training on the protocol will 
be performed. 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 improvement in their facial wrinkles. 
 
CONSIDERATION OF PATIENT PREFERENCE INFORMATION: 
Many physicians support the use of radiofrequency devices for non-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 efficacy results while using the TempSure device in this study. 
 
CONCLUSION: 
This device is determined to be a non-significant risk study and will be using a handpiece not cleared 
for use by the FDA. The Icon device is cleared for use by the FDA but may not be used within its 
currently cleared instructions for use. The risks posed to the subjects and integrity of data are 
acceptable.  
 
Patient population to be enrolled in this clinical study:  
Total anticipated population: 50 Subjects 
Age Range: 18 years of age or older 
Gender: Male or Female 
Condition: Facial Wrinkles (TempSure) and benign pigmented and/or vascular lesions (Icon) 
 
4.0  
DEVICE DESCRIPTION AND SPECIFICATIONS 
The TempSure® device used in this study is currently cleared by the U.S. Food and Drug 
Administration (the FDA). The TempSure® device received 510(k) clearance under K171262 on 
September 22, 2017 for: 
• The 10mm, 15mm, and 20mm TempSure Envi handpieces are indicated for non-ablative 
treatment of mild to moderate facial wrinkles and rhytids. 
• The 18mm, 25mm, and 30mm TempSure Envi handpieces provide heating for the 
purpose of elevating tissue temperature for selected medical conditions such as 
temporary relief of pain, muscle spasms, and increase in local circulation. 
• The Massage device is intended to provide a temporary reduction in the appearance of 
cellulite. 
• Coagulation/Hemostasis: Using the surgical handpieces and accessories, general surgical 
procedures including urologic, thoracic, plastic, reconstructive, and gynecological 
procedures where electrosurgical coagulation of tissue is performed. 
And received 510(k) clearance under K182365 on October 24, 2018 for: 
• Cutting: snoring. submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), 

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myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, 
skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, 
skin tags and blepharoplasty. 
• Blended Cutting and Coagulation: snoring, submucosal palatal shrinkage, traditional 
uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis 
treatment, turbinate shrinkage, skin tags, papilloma keloids, keratosis, verrucae, basal cell 
carcinoma, nevi, fistulas, epithelidma, cosmetic repairs, cysts, abscesses, and development 
of skin flaps. 
• Fulguration: basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae, hemostasis. 
• Bipolar: pinpoint precise coagulation, pinpoint hemostasis in any field (wet or dry). Snoring, 
submucosal palatal, shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with 
effective hemorrhage control, epistaxis treatment and turbinate shrinkage 
The 60mm handpiece (under K190678 on July 24, 2019) and FlexSure applicators (under K200241 
on March 25, 2020) of the TempSure® device received 510(k) clearance to provide heating for the 
purpose of elevating tissue temperature for selected medical conditions such as temporary relief of 
pain, muscle spasms, and increase in local circulation. 
 
Changes to the TempSure® device are anticipated during the investigation as the Mini Envi 
handpiece is expected to receive clearance for use from the FDA. 
 
The TempSure® Device Specifications are: 
Surgical Connector 
1 surgical monopolar port 
Neutral Connector  
One universal neutral connector compatible with Cynosure neutral 
electrodes 
Smart Handpiece 
Connectors  
One 4-pin circular connector for both RF energy delivery and 
temperature sensing (monopolar) 
Modes of 
Operation  
Select the Smart Handpiece or Surgical mode of operation 
Maximum Power 
Temperature-Sensing Handpieces 
 10mm, 15mm, and 20mm handpieces have a maximum 
GUI setting of 70, which provides output power of 120 
Watts (+/- 20%). 
 18mm handpiece has a maximum GUI setting of 25, 
which provides output power of 25 Watts (+/-20%). 
 25mm and 30mm handpieces have a maximum GUI 
setting of 80, which provides output power of 165Watts 
(+/- 20%). 
 60mm handpieces have a maximum GUI setting of 100, 
which provides output power of 300 Watts (+/- 20%).  
 FlexSure applicators are controlled by setting the 
temperature. During treatment, power can reach a 
maximum output of 300 Watts (+/- 20%).  
 
Ensuring that the neutral pad recommended for use with the 60mm 
handpiece and flexible applicator has sufficient current carrying 
capacity so as to assure that there is no unacceptable temperature 
rise under the pad is an essential performance of the TempSure 
platform. 

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The TempSure® consumables are: Handpieces, NEM Pads 
 
The Icon device used in this study is currently cleared by the U.S. Food and Drug Administration 
(the FDA). The Icon device received 510(k) clearance under K103664 on March 17, 2011 for: 
 
The Max Series Intense Pulsed Light Handpieces are intended for the treatment of 
inflammatory acne (acne vulgaris) and for the treatment of benign pigmented epidermal 
and cutaneous lesions, including warts, scars and striae; removal of unwanted hair from 
skin types 1-VI, and to effect stable long-term, or permanent, hair reduction; treatment 
of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and 
treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, 
telangiectasias, rosacea, facial and leg veins. 
 
The Icon Device Specifications for the Max G handpiece are: 
 
 
5.0 
MONITORING PROCEDURES  

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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: Lisa Tocci 
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 TempSure® 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 TempSure® Operator’s 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 
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.  

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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.   
 
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 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 

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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. The subject will be asked to remove 
jewelry, 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 TempSure® treatments:  
• 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. 

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• 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.  
 
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: 

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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 1 working day of serious adverse events as 
defined by FDA guidelines.  
 
 
15.0  PROTOCOL DEVIATIONS 
All requests for protocol deviations by the Investigator must 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, LLC, 
the manufacturer of the test device (Sponsor), and consultants that are helping conduct the study.  
The Sponsor and its consultants will analyze and evaluate these results and information and may 
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 

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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. 
The Investigator’s report must be submitted within 
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. 

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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 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. 
 
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 
 

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The report of prior investigations or predicates are: 
 
Device 
Determination 
510(k) 
TempSure 
Meets the criteria for exemption from IDE 
regulations, non-significant risk 
K200241 
TempSure 
Meets the criteria for exemption from IDE 
regulations, non-significant risk 
K190678 
TempSure 
Meets the criteria for exemption from IDE 
regulations, non-significant risk 
K182365 
TempSure 
Meets the criteria for exemption from IDE 
regulations, non-significant risk 
K171262 
Icon  
Meets the criteria for exemption from IDE 
regulations, non-significant risk 
K103664 
Icon 
Meets the criteria for exemption from IDE 
regulations, non-significant risk 
K110907 
 
Protocol 
Device 
IRB Name 
Determination 
Initial IRB 
Approval Date 
7027-FS01-2021 
TempSure 
AIRB 
Meets the criteria for 
exemption from IDE 
regulations, non-significant 
risk 
04/01/2021 
7027-FS01-2021 
TempSure 
AIRB 
Meets the criteria for 
exemption from IDE 
regulations, non-significant 
risk 
04/01/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX A: 
Protocol Revisions Tracker 
 
Version 
Date 
Editor 
Description 
July 17, 2021 
Kristy Luis 
IRB Submission 
August 23, 2021 
Kristy Luis 
Increased the number of patients from 30 to 50. 
Added Dr. Doherty as site #3. Added the use of the 
Icon device. Added 2 groups of subjects (Group A 
treated with only Tempsure, Group B treated with 
TempSure and Icon). Added Subject Questionnaires 
to be performed Pre-Treatment 1, Post Treatment 1, 
and at the Follow Up visits. Other Administrative 
edits. 
September 10, 2021 
Kristy Luis 
Removed “pigmentation” as condition to be treated 
with Icon and replaced with “benign pigmented and 
vascular lesions”. 
January 20, 2022 
Kristy Luis 
Added some subjects may be asked to return for an 
optional 5th treatment (2 – 3 weeks post last 
treatment) with the Icon device (and/or TempSure 
device) after the completion of their 4 treatments at 
the discretion of the Investigator to Group B. Other 
administrative changes.  
 
 
 

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APPENDIX B: 
 
 

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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 
3 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 
4 Stampar, M. (2011). The Pelleve Procedure: An Effective Method for Facial Wrinkle Reduction and Skin 
Tightening. Facial Plastic Surgery Clinics of North America, 19(2), 335-345. 
doi:10.1016/j.fsc.2011.05.012