Picosure Alexandrite Laser and Revlite Nd:Yag Laser for the Treatment of Unwanted Tattoos
Phase: NA
Conditions: Unwanted Tattoos
Sponsor: Cynosure, Inc.

Protocol: CYN13-PICOREVLITE 
 
Cynosure, Inc. 
 
VERSION 5:  March 1, 2016 
 
Page 1 of 14 
 
 
 
 
 
 
 
 
 
Protocol: 
CYN13-PicoRevlite 
 
 
PICOSURE Alexandrite Laser AND REVLITE Nd:Yag Laser 
FOR THE TREATMENT OF UNWANTED TATTOOS 
 
Document Date: March 1, 2016 
Uploaded onto clinicaltrials.gov 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol: CYN13-PICOREVLITE 
 
Cynosure, Inc. 
 
VERSION 5:  March 1, 2016 
 
Page 2 of 14 
 
 
 
 
 
 
 
 
 
 
 PICOSURE Alexandrite Laser AND REVLITE Nd:Yag Laser  
FOR THE TREATMENT OF UNWANTED TATTOOS 
 
PROTOCOL #: CYN13-PICOREVLITE 
 
 
 
 
 
 
 
 
 
 
 
 
CYNOSURE, INC. 
5 CARLISLE ROAD 
WESTFORD, MA 01886 
800-886-2966 
(978) 256-6556 FAX 
 
 

Protocol: CYN13-PICOREVLITE 
 
Cynosure, Inc. 
 
VERSION 5:  March 1, 2016 
 
Page 3 of 14 
INVESTIGATOR AGREEMENT 
 
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 comply with Good Clinical Practice (GCP) regulations and guidelines during the 
conduct of this study. 
 
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 laser and the conduct of the study. 
 
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. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Investigator’s Signature  
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
Name of Investigator (Typed or Printed)  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Address of Investigator (Typed or Printed) 
 

Protocol: CYN13-PICOREVLITE 
 
Cynosure, Inc. 
 
VERSION 5:  March 1, 2016 
 
Page 4 of 14 
 
Protocol Number: CYN13-PICOREV 
 
 
Investigator Contact Information: 
Sean Doherty, M.D. 
 
Sponsor Contact Information: 
Jennifer Civiok 
Sr. Clinical Research Associate 
5 Carlisle Road 
Westford, MA 01886 
Phone: 978-367-8775 
Fax: 978.256.6556 
Email: jciviok@cynosure.com 

Protocol: CYN13-PICOREVLITE 
 
Cynosure, Inc. 
 
VERSION 5:  March 1, 2016 
 
Page 5 of 14 
TABLE OF CONTENTS 
1.  
PURPOSE AND OBJECTIVES 
 
 
 
 
 
 
2. 
BACKGROUND 
 
 
 
 
 
 
 
 
3. 
DEVICE DESCRIPTION 
 
 
 
 
 
 
 
4. 
SUBJECT POPULATION AND SELECTION CRITERIA 
 
 
 
5. 
STUDY DESIGN 
 
 
 
 
 
 
 
 
6. 
RISK MANAGEMENT 
 
 
 
 
 
 
 
7. 
ADVERSE REACTIONS 
 
 
 
 
 
 
 
8. 
PROTOCOL DEVIATIONS 
 
 
 
 
 
 
 
9. 
DATA COLLECTION AND MONITORING 
 
 
 
 
 
10. 
CONFIDENTIALITY AND DISCLOSURE OF MEDICAL INFORMATION  
11. 
DEVICE SPECIFICATIONS  
 
 
 
 
 
 
12. 
LABELING 
 
 
 
 
 
 
 
 
 
13. 
CLINICAL RESEARCH CONDUCT  
 
 
 
 
 
14. 
INFORMED CONSENT 
 
 
 
 
 
 
 
15. 
DATA ANALYSIS 
 
 
 
 
 
 
 
 
16. 
REPORTING FOR THE STUDY 
 
 
 
 
 
 
17. 
DISCLOSURE 
 
 
 
 
 
 
 
 
18. 
RESPONSIBILITY OF THE INVESTIGATOR 
 
 
 
 
19. 
PROCEDURE FOR AMMENDMENTS TO THE PROTOCOL 
 
 
20. 
INSTITUTIONAL REVIEW BOARD  
 
 
 
 
 
21. 
TERMINATION OF STUDY  
 
 
 
 
 
 
22. 
STUDY RECORDS 
 
 
 
 
 
 
 
 
23. 
CONFIDENTIALITY  
 
 
 
 
 
 
 
24. 
DATA SECURITY 
 
 
 
 
 
 
 
 
 
APPENDICES: 
A. 
Informed Consent Form 
B. 
Case Report Form 
C. 
Postoperative Instructions 
D. 
Operator Manual for the PICOSURE Laser 
E. 
Operator Manual for the Revlite Laser 
 
 
 

Protocol: CYN13-PICOREVLITE 
 
Cynosure, Inc. 
 
VERSION 5:  March 1, 2016 
 
Page 6 of 14 
1.  PURPOSE AND OBJECTIVES 
This is a prospective study to evaluate the PICOSURE Laser System for the treatment of 
unwanted tattoos.  
Objectives: 
1. Establish Treatment parameters 
2. Compare to Revlite Laser System 
3. To assess safety through recording of side effects during course of study. 
 
2.  BACKGROUND 
Lasers are accepted devices for the removal of unwanted tattoos.  Currently, Q switched 
Alexandrite and Nd:YAG lasers emitting wavelengths of 1064nm, 755nm and 532nm, are 
routinely used in the removal of unwanted tattoos.  The lasers’ Q-switched mode of operation 
allows the delivery of short (nanosecond) pulses that can disrupt or shatter the tattoo ink or 
pigment which is subsequently cleared by the body’s own cells, the phagocytes or 
macrophages.   
 
Tattoo removal often requires a series of treatments performed approximately every 6 weeks.  
Tattoos may be removed in as few as 2-4 treatments, but others may require six to ten, or even 
as many as twenty treatments to achieve clearance.  Unfortunately, not all tattoos can be 
removed completely.   
 
3.  DEVICE DESCRIPTION 
The RevLite Q-Switched Nd:YAG is cleared under FDA  K083899 for Tattoo Removal. 
The PICOSURE laser has been cleared by the FDA under 510 (k) K121346 for the removal of 
tattoos and benign pigmented lesions. It is believed that these shorter pulses may be more 
efficient in disrupting pigment and possibly resulting in better treatment outcomes. 
 
The sponsor deems this device a non significant risk.  The system was tested to ensure 
compliance with federal laser performance standards, 21CRF Part 1040.  
 
See section 11 for full specifications. 
 
4. SUBJECT POPULATION AND SELECTION CRITERIA 
The study subject population will consist of up to 100 subjects.  Up to 10 subjects will be 
receiving split tattoo treatments with the Revlite and/or the Pico Laser.  The subjects will meet 
the selection criteria described as follows: 
 
4.1 Inclusion Criteria 
1. Is a healthy male or female between 18 and 65 years old. 
2. Is willing to consent to participate in the study. 
3. Is willing to comply with all requirements of the study including being photographed, 
following post treatment care and attending all treatment and follow up visits. 
 
4.2 Exclusion Criteria: 
1. The subject is female and pregnant, has been pregnant within the last 3 months, is 
currently breast feeding or planning a pregnancy during the study period.  
2. The subject is hypersensitive to light exposure OR takes photo sensitizing 
medication.  
3. The subject has active or localized systemic infections. 

Protocol: CYN13-PICOREVLITE 
 
Cynosure, Inc. 
 
VERSION 5:  March 1, 2016 
 
Page 7 of 14 
4. The subject has a coagulation disorder or is currently using anti-coagulation 
medication (including but not limited to heavy aspirin therapy {greater than 81 mg per 
day}). 
5. The subject has any condition which, in the investigator’s opinion, would make it 
unsafe for the subject to participate in this research study. 
6. 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 
3 months prior to entering this study.  
7. The subject has used Accutane within 6 months prior to enrollment. 
8. The subject has the need to be exposed to artificial tanning devices or excessive 
sunlight during the trial. 
9. The subject has had prior treatment with parenteral gold therapy (gold sodium 
thiomalate). 
10. The subject has a history of keloid scar formation. 
11. The subject has evidence of compromised wound healing. 
12. The subject has a history of basal cell carcinoma, squamous cell carcinoma or 
melanoma. 
13. The subject has a history of immunosuppression/immune deficiency disorders 
(including HIV infection or AIDS) or use of immunosuppressive medications or has 
an autoimmune disorder.14. The subject has red tattoo ink allergy 
 
5. STUDY DESIGN 
Subjects will receive up to 10 laser treatments on their unwanted tattoo.  The study subjects will 
return to the investigator site for follow-up evaluations.  See section 5.4 for schedule and visit 
details. 
 
5.1 Subject Assignment 
All potential subjects will undergo a pre-screening interview where their medical history will 
be reviewed and inclusion/exclusion criteria verified. Subjects meeting the criteria for 
enrollment in the study will sign the informed consent form and be assigned a subject 
identification number.  Subject identification numbers will be generated chronologically and 
assigned only to subjects who have met all inclusion/exclusion criteria and signed the 
informed consent form. Subjects will be de-identified through their subject identification 
number, which will be stored in a secure location. 
 
5.2 Screening 
• 
Consent must be signed. 
• 
Medical history of each subject will be reviewed and inclusion/exclusion criteria 
verified.  A limited physical exam (no pelvic and no rectal exam). 
• 
Subjects meeting the criteria for enrollment in the study will sign the informed 
consent form and be assigned a subject identification number. 
 
5.3 Laser Treatment 
 
5.3.1 Pre-Treatment 
• 
Photographs will be taken of the treatment area(s). 
• 
Female subjects will be asked if they are pregnant and the date of their last 
menstrual cycle (no pregnancy testing will be conducted). 
 
 
 

Protocol: CYN13-PICOREVLITE 
 
Cynosure, Inc. 
 
VERSION 5:  March 1, 2016 
 
Page 8 of 14 
5.3.2 Procedure 
• 
All laser operators and subjects will wear protective eye glasses during the laser 
treatments  
• 
Subjects will receive up to 10 treatments, administered every 4-12 weeks. 
• 
Adjunctive tissue cooling with chilled air (Zimmer Cooler) will be used during 
and/or after treatment to enhance comfort.  If subjects require additional means 
of reducing treatment or post-treatment discomfort, an optional application of 
topical anesthesia, such as EMLA® , ElaMax® or BLT cream for up to 60 
minutes prior to treatment may be used at the discretion of the Investigator.   
 
5.3.3 Technique 
• 
The appropriate parameters including the number of pulses will be determined by 
the physician. 
• 
The laser hand piece distance gauge tip will be in contact with the skin.  
 
5.3.4 Post Treatment 
• 
Standard post-op wound care instructions will be reviewed. 
• 
Aquaphor will be applied to the treatment and it will be covered with a non stick 
pad.  The subjects will be instructed to change the pad twice per day for one 
week. 
• 
Subjects may resume normal activities after treatment. 
• 
If treatment area is in a location that is exposed to the sun, the treatment area 
should remain covered at all times.  If this is not possible, sun block with a broad 
spectrum UVA, UVB sunscreen of SPF 30 or higher should be applied to the 
treated area every 2 hours when exposed to sun and, and should apply 
protection throughout the study. 
• 
This information is also included in the Informed Consent Form. 
 
5.3.5 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. 
5.4 Subject visit Schedule 
• 
Visits will be required per schedule below:  
 
Procedure 
Screening
/Baseline 
Treatment 
1-10 
(every 4-12 
weeks) 
2 Month 
Follow Up 
(+/- 1 Month) 
Consent 
X 
 
 
Medical History 
X 
 
 
Photos 
X 
X 
X 
Treatment 
 
X 
 
Events 
Assessment 
X 
X 
X 
Satisfaction 
Questionnaire  
(Subject and PI) 
 
 
X 
 

Protocol: CYN13-PICOREVLITE 
 
Cynosure, Inc. 
 
VERSION 5:  March 1, 2016 
 
Page 9 of 14 
The sponsor anticipates that all subjects can be enrolled within 2 months. Treatment and 
follow-up on the last subject entered into the study will add at least another 12 months to 
the study duration. Subject participation in the study is expected to last up to 13 months.  
The total study duration is anticipated to last a total of 15 months. 
 
5.5 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 course of 
the study.  Date of last menstrual cycle will be recorded.   
 
If the subject thinks they have become pregnant during the study it is important that they 
inform the study doctor immediately. If she becomes pregnant or thinks that she may be 
pregnant, she will be removed from the study and will ask to perform a final evaluation.  
The study doctor should refer her to seek obstetric care, the cost of which will be her 
responsibility. The study doctor may request to track the pregnancy and will report the 
pregnancy to the Sponsor and the IRB.  
 
5.5 Right to Withdraw or Removal from Study 
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 study doctor at the contact information listed on page 
one of the informed consent form. They will be asked to come to the study clinic or 
doctor’s office to complete some end of study procedures which are listed in the 
Withdrawal Procedures section of the informed consent form.  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 doctors participating in the study prior 
to completion. 
 
5.6 Photography 
Photos will be taken with an appropriate high resolution digital camera. It is important to 
record and carefully reproduce the camera settings (lighting, distance from the treatment 
area, background, polarization, etc.) at each visit, so that photos are suitable for 
comparison.  If the subject does not wish to have their photos taken, they cannot be in 
the study. 
 
5.7 Evaluation Methods 
5.7.1 Tattoo Clearance 
A photographic Scale will be used to evaluate outcomes. Blinded evaluators will 
grade the tattoo clearance of photographs taken of the subjects at baseline and post 
treatment. The results will be compared to determine improvement. 
 
5.7.2 Investigator and Subject Questionnaires:  

Protocol: CYN13-PICOREVLITE 
 
Cynosure, Inc. 
 
VERSION 5:  March 1, 2016 
 
Page 10 of 14 
Questionnaires will be used to assess Investigator and Subject satisfaction at the 2 
month follow up visit with their cosmetic results when compared to baseline photos 
using a six point scale ranging from “extremely satisfied” to “extremely dissatisfied”.   
 
5.7.3 Events 
Recording of events will take place at all visits. 
 
6. RISK MANAGEMENT 
The investigator in this clinical trial has been invited to participate based on his previous 
experience with the use of laser systems in dermatology. Experience with laser treatments is 
the most critical element in managing subject risk in this trial.  Additionally, all laser operators 
and subjects will wear protective eye glasses during the laser treatments.  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. 
 
7.  ADVERSE REACTIONS 
Side effects means anticipated reactions to treatment and typically resolve spontaneously.  
Anticipated events means reactions to treatment previously observed that may require medical 
intervention but are not serious in nature.   
 
All adverse events that occur, starting from the time of the first treatment will be recorded in the 
Source Documents.  
Adverse Events occurring will be captured and followed until the condition resolves, stabilizes, 
or is otherwise explained, or the subject is lost to follow-up. Subjects will be instructed that they 
may contact the Principal Investigator at any time throughout the course of the study.    
The Investigator will review each event and assess its relationship to the laser treatments (not 
related, unlikely, possible, probable, and highly probable). The following definitions will be used 
for rating relationship to the laser 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. 
• 
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 

Protocol: CYN13-PICOREVLITE 
 
Cynosure, Inc. 
 
VERSION 5:  March 1, 2016 
 
Page 11 of 14 
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. 
 
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 to interfere with normal everyday activities. 
• 
Severe – incapacitating and/or preventing normal everyday activities. 
 
A Serious Adverse Event 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 Medical Monitor 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 Medical Monitor will enter the SAE information into the database and submit a desk copy of 
the complete SAE report to the files.  
 
Adverse events, whether serious or non-serious, will be followed until the condition is resolved, 
stabilized, or otherwise explained, or the subject is lost to follow-up.  Adverse events will be 
captured up to one week after a subject completes 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, or unknown (lost to follow-up).  
Following the resolution of any study-associated adverse events there will be no further adverse 
event reports for that subject. 
 
PICOSURE/REVLITE 
Risks to the subjects who participate in this study are the same as those for the subject 
undergoing infrared laser treatment.  Eye injury due to direct ocular laser exposure requires the 
use of protective eyewear. with an optical density of 755nm- ≥ 7.0 OD,532nm-≥ 7 OD, 1064nm 
≥ 7OD.  
 
Side effects of the laser treatment can include; Pain, blister, redness, swelling, bruising, pin 
point bleeding, crusting, itching, Some anticipated events from the treatment may include; 
infection, , allergic reaction, scarring, burn, hypopigmentation and hyperpigmentation. 
 
Proper pre and post treatment standards and wound care reduces the risk of these 

Protocol: CYN13-PICOREVLITE 
 
Cynosure, Inc. 
 
VERSION 5:  March 1, 2016 
 
Page 12 of 14 
complications; however these conditions may or may not resolve over time. 
 
Incomplete removal is relatively common,  
 
Sunburn may occur if subject has unprotected exposure to ultraviolet (UV) light.  
 
 
8. 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 and IRB in writing within 10 days. 
 
9. DATA COLLECTION AND MONITORING 
The sponsor will train the site and be present at initiation of treatment.  The sponsor will also 
monitor the site at various intervals and upon request expects to receive intermediate results by 
fax following each visit to evaluate treatment progress.  Case Report Forms and Investigator 
Binders will be reviewed for current data.  The sponsor will collect data at the end of the follow 
up period.  The sponsor will list the study on clinicaltrials.gov as required by FDA regulations. 
 
10. 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 research 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, 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 and Drug Administration (the FDA) or other regulatory 
agencies in the United States and/or foreign countries.  Study records will be assigned a code 
number by the study team and the subject will ordinarily not be identified by name in the study 
records that are sent to the Sponsor and its consultants.  However, The Sponsor and its 
consultants will have the right to see the complete study records.   
 
The research facility will review and use the study records only for purposes of this study.  They 
will keep the subject 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 can not be 
guaranteed. However, the Sponsor and its consultants will only use the information for purposes 
of the study and will not disclose the study records to parties other than the FDA and similar 
government agencies, unless disclosure is required by law.  If reports or articles are written 
about the study, you will not be identified by name in them. The study records may be retained 
at the research facility indefinitely following the completion of the study. 

Protocol: CYN13-PICOREVLITE 
 
Cynosure, Inc. 
 
VERSION 5:  March 1, 2016 
 
Page 13 of 14 
 
11. DEVICE SPECIFICATIONS 
                         The Pico Laser is manufactured by Cynosure Inc.  
Device Type 
Alexandrite Laser 
Wavelength  
755nm, 532nm, 1064nm 
Pulse width 
0.5 - 0.8ns 
Fluence 
0.5 - 6J/cm2 
Spot Size 
2 –10mm  
 
                      The Revlite Laser is manufactured by Conbio, a Cynosure company. 
System Type 
Nd:YAG 
Wavelength 
1064nm,  532nm 
Pulse Width 
5-20ns 
Spot Size  
1.2-8mm 
Fluence 
1.5 – 21 J/cm2 
 
 
 
 
 
 
12. LABELING 
Sample labeling and directions for use are contained in the Operation Manual for this device. 
 
13. 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. 
 
14. INFORMED CONSENT  
During the screening, the investigator or a representative on their behalf will perform the 
informed consent process.  At the screening, all aspects of the study will be discussed with the 
subject.  A signed informed consent form (ICF) shall be obtained from the subject, clearly 
indicating his/her understanding of the study requirements, as well as the possible risks involved 
with study participation.  
 
15. DATA ANALYSIS  
In order to meet the objectives of our clinical study we will analyze tattoo clearance scores, PI 
and Subject satisfaction, and events. 
 
16. 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, and the statistical analysis described in the data analysis section of this 
protocol. 
 
17. DISCLOSURE 
The Principal Investigator, Medical Monitor, sponsor representative, and Cynosure employees 
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. 

Protocol: CYN13-PICOREVLITE 
 
Cynosure, Inc. 
 
VERSION 5:  March 1, 2016 
 
Page 14 of 14 
 
18. RESPONSIBILITY OF THE INVESTIGATOR 
The Investigator is responsible for ensuring that the clinical study is performed in accordance 
with the Declaration of Helsinki (revised version of Edinburgh, Scotland, 2000 including notes of 
clarification, Washington, 2002 and Tokyo, 2004) and FDA Good Clinical Practice Regulations 
(21 CFR parts 50, 56, and 812).  Investigators will supply information to the sponsor such that 
the sponsor can comply with the Financial Disclosure Rules (21 CFR part 54). 
 
19. PROCEDURE FOR AMMENDMENTS TO THE 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. 
 
20. INSTITUTIONAL REVIEW BOARD 
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. 
 
21. 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. 
 
22. STUDY RECORDS 
All records and documents pertaining to the study will be maintained in appropriate permanent 
files as per the ICH guidelines for Essential Documents for the Conduct of a Clinical Trial and 21 
CFR 11, and will be available for inspection by the Sponsor, Sponsor designee, or the Food and 
Drug Administration at any time. 
 
23. CONFIDENTIALITY 
After the informed consent has been signed, each subject will be entered on a 
screening/enrollment log, which will be kept with the study records.  Once a subject is 
consented, a unique subject identification number will be assigned.  No two subjects will have 
the same subject identification number.  This subject identification number will identify the 
subject throughout the study and will be used for all source documents, and Data Collection 
Forms.  The subject identification number will be held confidential so far as permitted by law.  
Investigative site staff, the Sponsor or its designee, and, under certain circumstances, the FDA 
and Institutional Review Board (IRB) will be able to inspect and have access to the subject 
identification number and the confidential data that it links to.  Any publication or presentation of 
data will not contain any identifiable subject information. 
 
24. 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.