An Evaluation of the Effect of the Erchonia Corporation Violet Zerona® Z6 for Body Contouring
Phase: NA
Conditions: Circumference Reduction
Sponsor: Erchonia Corporation

 
 
 
NCT05674292 
 
 
ERCHONIA CORPORATION 
VIOLET ZERONA® Z6 OTC 
 
 
An Evaluation of the Effect of the 
Erchonia Corporation Violet 
ZERONA® Z6 for Body 
Contouring  
 
 
 
 
 
Version 1.0 
March 22, 2022 

Erchonia Corporation Violet ZERONA® Z6 OTC Efficacy Study Protocol 
Version 1.0 
 
March 22, 2022 
 
 
 
Table of Contents 
STUDY INFORMATION ......................................................................................................... 1 
SPONSOR ............................................................................................................................. 1 
REGULATORY AND CLINICAL CONSULTANT .................................................................... 1 
MONITOR .............................................................................................................................. 1 
INSTITUTIONAL REVIEW BOARD ........................................................................................ 1 
INVESTIGATORS .................................................................................................................. 1 
PURPOSE OF STUDY ........................................................................................................... 2 
STUDY DURATION ................................................................................................................ 2 
INDICATION FOR USE .......................................................................................................... 2 
EXPECTED RESULTS ........................................................................................................... 2 
REGULATORY BACKGROUND AND JUSTIFICATION FOR THE CURRENT STUDY ......... 3 
STUDY DEVICE ..................................................................................................................... 5 
STUDY DESIGN ...................................................................................................................11 
STUDY PROCEDURES ........................................................................................................13 
PRE-PROCEDURE ACTIVITIES ...........................................................................................13 
    PRE-PROCEDURE STUDY MEASUREMENT                                                                       14 
PROCEDURE ADMINISTRATION ACTIVITIES ....................................................................14 
PROCEDURE ASSESSMENTS ............................................................................................14 
STATISTICAL ANALYSIS PLAN ...........................................................................................15 
 
 
 
 
 
 
APPENDICES 
APPENDIX A:  LETTER OF APPLICATION FOR NON-SIGNIFICANT RISK (NSR) 
DETERMINATION 
 APPENDIX B: INFORMED CONSENT FORM 
APPENDIX C: CASE REPORT FORMS 
APPENDIX D: VIOLET ZERONA® Z6 OTC INSTALLATION AND PROPER USE 
REFERENCE GUIDE

 
 
Erchonia Corporation Violet ZERONA® Z6 OTC Efficacy Study Protocol 
 
Version 1.0 
 
 
 
            Page 1    
 
 
March 22, 2022 
 
 
 
STUDY INFORMATION 
 
SPONSOR 
Erchonia Corporation 
650 Atlantis Rd.  
Melbourne, FL  32904 
 
Contact: Mr. Steven Shanks, President 
Telephone: 321-473-1251 
E-mail: sshanks@erchonia.com 
  
REGULATORY AND CLINICAL CONSULTANT 
Regulatory Insight Inc. 
219 East Harbor 
Hendersonville, TN 37075 
Contact: Elvira Cawthon, Clinical Consultant 
Telephone: 615-447-5150 
E-mail: elvira@reginsight.com  
 
MONITOR 
Erchonia Corporation 
650 Atlantis Rd.  
Melbourne, FL  32904 
 
Contact: Travis Sammons 
Telephone: 321-473-1251 ext. 501 
E-mail: tsammons@erchonia.com 
 
INSTITUTIONAL REVIEW BOARD 
WIRB- Copernicus Group (WCG) 
1019 39th Avenue SE Suite 120 
Puyallup, WA 98374-2115 
Phone: 1-855-818-2289 
 
INVESTIGATORS (DEVICE USER) 
• Jamie Thayer 
2250 US 41 South 
Marquette, MI 49855  
Phone : (906) 360-9774 
E-mail : jamieanytimefit@yahoo.com 
 
 
• Tracey Hishon 
43494 Woodward Ste 101 
Bloomfield Hills, MI 48302 
Phone: (248) 635-7171 
E-mail: traceyhishon@yahoo.com 
 
 
 
 
 
 
 
 

 
 
Erchonia Corporation Violet ZERONA® Z6 OTC Efficacy Study Protocol 
 
Version 1.0 
 
 
 
            Page 2    
 
 
March 22, 2022 
 
 
 
 
PURPOSE OF STUDY 
The purpose of this clinical study is to determine the effectiveness of the Erchonia Violet 
ZERONA® Z6 OTC (manufactured by Erchonia Corporation (the Company), an over-the-
counter (OTC) laser device, in providing noninvasive body circumference reduction. 
 
STUDY DURATION 
The estimated total duration of the study is 2 weeks. 
 
INDICATION FOR USE 
The indication (claim) being sought through support of the results of this clinical study is:  
 
“The Erchonia Violet ZERONA® Z6 OTC is indicated for use as a non-invasive dermatological 
aesthetic treatment for the reduction of body circumference.” 
 
The Erchonia Violet ZERONA® Z6 OTC is intended for Over-the-Counter (OTC) use. 
 
The indication for use and intended use of the Erchonia Violet ZERONA® Z6 OTC is identical 
to the predicate device, the Erchonia ZERONA® Z6 OTC, as FDA cleared under K162578:  
 
“The Erchonia ZERONA Z6 OTC is indicated for use as a non-invasive dermatological 
aesthetic treatment for the reduction of body circumference.”  
 
It is cleared for Over-the-Counter (OTC) use. 
 
It is intended that the results of this clinical study be used to support a 510(k) submission to 
seek FDA clearance to market the Erchonia Violet ZERONA® Z6 OTC for the same indication 
for use as that cleared for the predicate device, the Erchonia ZERONA® Z6 OTC (K162578), 
by demonstrating that the efficacy of application of the Erchonia Violet ZERONA® Z6 OTC is 
non-inferior to the efficacy of application of the Erchonia ZERONA® Z6 OTC (K162578) for 
the reduction of body circumference of the waist, hips, and bilateral thighs when applied in the 
over-the-counter setting. 
 
EXPECTED RESULTS 
Following completion of the study treatment administration protocol, it is anticipated that 
compared with the Erchonia ZERONA® Z6 OTC red diode laser, application of treatment 
administration with the Erchonia Violet ZERONA® Z6 OTC will yield non-inferior (equivalent 
or superior) results with respect to mean decrease in subjects’ combined waist-hips-bilateral 
thighs circumference measurements relative to baseline. 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Erchonia Corporation Violet ZERONA® Z6 OTC Efficacy Study Protocol 
 
Version 1.0 
 
 
 
            Page 3    
 
 
March 22, 2022 
 
 
 
REGULATORY BACKGROUND AND JUSTIFICATION FOR THE CURRENT 
STUDY 
 
The intended regulatory pathway to seek clearance for the Erchonia Violet ZERONA® Z6 OTC 
for the intended indication is through a 510(k) submission with supportive clinical data from the 
outcome of this clinical study protocol. 
 
The intended predicate device is the Erchonia ZERONA® Z6 OTC, previously FDA cleared 
under K162578. 
 
The Erchonia ZERONA® Z6 OTC is currently FDA cleared under K162578 for use as a non-
invasive dermatological aesthetic treatment for the reduction of body circumference. It is cleared 
for Over-the-Counter (OTC) use.  
 
Preceding its clearance under K162578, the Erchonia Zerona® Z6 OTC received FDA 
clearance under K143007 for use as a non-invasive dermatological aesthetic treatment for the 
reduction of circumference of hips, waist, and thighs. K143007 was supported by the results of a 
Human Factors Validation and Testing Study that evaluated the lay user’s ability to operate the 
device safely, correctly, and effectively per the instructions in the User’s Manual. In that study, 
22 lay user subjects administered the treatment with the Zerona® Z6 OTC to 22 client subjects. 
The outcome of that study demonstrated that the lay users successfully understood the 
information in the User’s Manual and were able to follow the instructions to operate the device 
and administer treatments safely, correctly, and effectively. All treated subjects in that study 
received an active course of 6 treatments across 2 weeks administered by the lay users. The 
mean circumference reduction across the waist, hips and bilateral thighs for those subjects was 
-3.7 inches, a statistically significant finding of equivalency to the precedent prospective 
randomized controlled trial (RCT) evaluating efficacy of the Erchonia ZERONA® for noninvasive 
circumference reduction of the waist, hips, and bilateral thighs. In that prior study, 67 males and 
females aged 18 to 65 years received the identical treatment protocol of 6 treatments with the 
Zerona® equally spaced across 2 weeks to the waist, hips, and bilateral thighs. The 35 subjects 
who received the active laser treatment attained an average total circumference reduction of 3.5 
inches compared with a mean decrease of 0.68 inches for the 32 subjects who received the 
sham treatment. 
 
In 2016, the above-mentioned predicate device, the Erchonia® ZERONA® Z6 OTC, received 
FDA market clearance “for use as a non-invasive dermatological aesthetic treatment for the 
reduction of body circumference”, under 510(k) K162578. 
 
It is intended that the results of the current proposed clinical study be used to support a 510(k) 
submission to FDA for clearance to market the Erchonia Violet ZERONA® Z6 OTC for the same 
indication for use as for the Erchonia ZERONA® Z6 OTC as cleared under K162578 by 
demonstrating that efficacy of application of the two devices are equivalent. 
 
The current clinical study protocol evaluating efficacy of the Erchonia Violet ZERONA® Z6 for 
the reduction of body circumference is based on the efficacy protocol for the clinical study 
whose results were submitted in support of clearance of the predicate device, the Erchonia 
Zerona® Z6 OTC, under K143007.  
 
The 510(k) submitted under K143007 additionally included a successful evaluation of Human 
Factors Testing and Validation. It is determined that a Human Factors Validation and Testing 

 
 
Erchonia Corporation Violet ZERONA® Z6 OTC Efficacy Study Protocol 
 
Version 1.0 
 
 
 
            Page 4    
 
 
March 22, 2022 
 
 
 
study is not applicable for the Erchonia Violet ZERONA® Z6 OTC as the Operational 
Instructions for Use for the Erchonia Violet ZERONA® Z6 OTC and additional safety and other 
information contained in the Violet ZERONA® Z6 OTC Installation and Proper Use Reference 
Guide are identical to those for use of the predicate laser, the Erchonia ZERONA® Z6 OTC, 
with the only differences being the visible light output (violet compared to red) and the duration 
of treatment administrations (20 minutes compared to 40 minutes, which is automatically 
programmed into the device and cannot be altered by the user), neither of which therefore 
impacts the user’s operation of the Violet ZERONA® Z6 OTC versus the ZERONA® Z6 OTC 
laser device, and therefore has no impact on the user’s ability to understand or apply the 
instructions for use contained in the Violet ZERONA® Z6 OTC Installation and Proper Use 
Reference Guide or to safely or effectively apply treatments with the device relative to that 
demonstrated for the predicate device.  The study population and all elements of the device 
protocol and the Violet ZERONA® Z6 OTC Installation and Proper Use Reference Guide other 
than the pre-programmed administration timing duration (as explained above) will be identical to 
that employed in evaluation of the Erchonia ZERONA® Z6 OTC device in support of K143007. 
 
Both the predicate and the subject laser devices have the same treatment protocol as will be 
evaluated for the Violet ZERONA® Z6 OTC in this current study: 6 treatments occurring over 2 
weeks: 3 treatments per week; each treatment every other day. 
 
Therefore, as usability has already been established, and all other variables of device user, use, 
and application are held constant, the goal of this study is solely to demonstrate that efficacy of 
application of violet light over 20 minutes per treatment administration procedure using the 
Erchonia ZERONA® Violet Z6 OTC is equivalent to application of red light over 40 minutes per 
treatment administration procedure using the Erchonia ZERONA® Z6 OTC with respect to 
reduction in body circumference attained.  
 
The rationale for evaluating efficacy of the application of violet diodes in this current study is that 
prior research and preliminary testing has demonstrated that non-inferior (equivalent or 
superior) results with respect to body circumference reduction can be attained with application 
of violet light compared with application of red light using the same treatment administration 
protocol but with lesser treatment administration time per treatment administration – 20 minutes 
versus 40 minutes, respectively, which is a significant time savings to the patient.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Erchonia Corporation Violet ZERONA® Z6 OTC Efficacy Study Protocol 
 
Version 1.0 
 
 
 
            Page 5    
 
 
March 22, 2022 
 
 
 
STUDY DEVICE 
 
DEVICE DESCRIPTION 
 
The Violet ZERONA® Z6 OTC laser is designed for client’s seeking noninvasive fat loss without 
invasive surgery.  Violet ZERONA® Z6 OTC allows the patient to continue their daily activities 
without interruptions from surgery, pain, wounds or garments.  The Violet ZERONA® Z6 OTC 
works by emulsifying adipose tissue which then releases into the interstitial space.  The excess 
fat is then passed through the body during its normal course of detoxification. The Violet 
ZERONA® Z6 was built on the clinical foundation of its predecessors, Zerona® and Zerona®-
AD, and ZERONA® Z6 OTC, which were proven through clinical studies to be safe and effective 
in the application of circumference reduction and noninvasive fat loss. 
 
The Erchonia Violet ZERONA® Z6 OTC is identical to the predecessor device, the Erchonia 
ZERONA® Z6 OTC cleared under K162578, with the differences being light output (visible violet 
compared to visible red) and duration of treatment administrations (20 minutes compared to 40 
minutes, which is automatically programmed into the device). The Installation and Proper Use 
Reference Guide for use for the Erchonia® Violet ZERONA® Z6 OTC are identical to those for 
use of the predecessor laser, the Erchonia® ZERONA® Z6 OTC; consisting of the same device 
set-up and same treatment protocol involving 6 treatments occurring over 2 weeks: 3 treatments 
per week; each treatment every other day. 
 
The Violet ZERONA® Z6 OTC emits a 405-nanometer wavelength with a tolerance of ±10 
nanometer, from each of the six specially created and patented electronic diodes.  Laser 
devices are typically constructed to emit a “spot” of light.  The Violet ZERONA® Z6 OTC laser 
utilizes internal mechanics that collects the light emitted from the laser diode and processes it 
through a proprietary patented lens, and then redirects the beam with a line refractor.  The laser 
applicator heads, each produce an output power of 23mW (± 2mW) measured. Laser diodes 
and adjustable laser arms are positioned no greater than 3-4 inches away from the client’s 
target treatment areas.  
 
The Violet ZERONA® Z6 OTC Laser device has been classified by the FDA/EC as a Class II/IIa 
device and a Class II/2 Laser.  This designation represents a current standard for use in order to 
ensure the safety of the patient.  A Class II/IIa Laser is determined to have a chronic viewing 
hazard.  The Violet ZERONA® Z6 OTC Laser device has been classified by the FDA Class II 
device and a Class 2 laser in accordance IEC 60825-1 (Complies with 21CFR 1040.10 and 21 
CFR 1040.11 by Laser Notice #50).  The performance parameters and intended use of the 
Erchonia Violet ZERONA® Z6 OTC are compliant to the internationally recognized safety 
testing standards for medical devices.  The testing of the Violet ZERONA® Z6 OTC device 
includes functional performance, electrical, safety and component verification, in accordance 
with the FDA QS requirement, validated annually through ISO 13485 audits.  The software 
incorporated into the operation of the Violet ZERONA® Z6 OTC complies with FDA and ISO 
Software Development and Validation regulations.  
 
The Violet ZERONA® Z6 OTC laser package is comprised of (1) Violet ZERONA® Z6 OTC 
Laser device, (1) Pair of Safety Glasses, (1) Power Cord, (1) Power Supply, (1) Tape Measure, 
and (1) Installation and Proper Use Reference Guide.   
 
 
 

 
 
Erchonia Corporation Violet ZERONA® Z6 OTC Efficacy Study Protocol 
 
Version 1.0 
 
 
 
            Page 6    
 
 
March 22, 2022 
 
 
 
DEVICE SPECIFICATIONS  
 
1. Laser Head Assembly 
2. Laser Output Head  
3. Power Pushbutton 
4. Boom Arm 
5. Arm Lock 
6. Touch Screen 
7. Main Upright of Base 
8. Power Inlet 
9. Wheel Locks 
10. Electrical Connector  
11. Locking Knob 
12. Power Cord 
13. External Power Supply 
 
 
 
 
 
 
Device 
• 
Weight: 71lbs / 32kg 
• 
Height: 70 in / 177.8 cm (Average – Adjustable) 
• 
Full Color Touch Screen Control Center 
• 
Four independent Adjustable Arms 
• 
4 locking Anti-static casters 
• 
Powder coated metal frame 
• 
Non-allergenic material finished with black carbon fiber 
• 
Applied Part: Type B 
• 
Leakage Current 0.3 -0.5 µA (Micro Amps) 
Laser 
• 
Six line generating diode modules  
• 
Output: 23mW +/- 2mW 
• 
Wavelength: 405 nm +/- 10nm 
• 
Duty Cycle: CW (Continuous 100%) 
 
Power 
• 
Source: 100-240VAC 50-60Hz 
 
Temperature 
• 
Operating Temp: 59 to 85°F (15 to 29°C) <50% Relative Humidity 
• 
Transporting: -22 to 158°F (-30 to 70°C) <75% Relative Humidity 
 
 
 
 
 
Fig. 1 

 
 
Erchonia Corporation Violet ZERONA® Z6 OTC Efficacy Study Protocol 
 
Version 1.0 
 
 
 
            Page 7    
 
 
March 22, 2022 
 
 
 
LASER HEAD ASSEMBLY [1] 
This six head assembly located on the end of the boom arm accommodates the lens, laser 
diodes and their associated electronics. 
 
LASER OUTPUT HEAD [2] 
The aluminum housing located on the end of the flex arms accommodates the lens, laser 
diodes, motors, and their associated electronics. 
 
POWER BUTTON (ON/OFF) [3] 
The Power Pushbutton allows the end user to turn the device ON “|” or OFF “O”. To turn the device ON 
the Power Supply (13) must be plugged into the device Power Inlet (8) and the Power Cord (12), with the 
other end of the power cord plugged into a wall socket. Once connected, the pushbutton will need to be 
pushed to the ON “|” position to power the device ON. When the pushbutton is in the ON “|” position an 
LED on the pushbutton will illuminate. 
 
LASER ARM [4] 
The Laser Arm serves to position the Laser Head Assembly [1] vertically only.  It is designed to 
be adjusted by intentional force from the end user.  This allows the end user to lower and raise 
the Laser Output Heads for proper positioning to the client for accurate treatment distance. 
 
ARM LOCK [5] 
The Arm Lock is the black lever attached to the side of the Laser Arm.  This is a secondary 
locking mechanism for the laser arm.  The arm tension can be adjusted or locked into position 
with the Arm Lock lever.  The lever is pulled out to place it in the desired position then locked 
back in place before turning. 
 
TOUCH SCREEN [6] 
The touch screen functions as a display screen and an input panel, providing information to the 
user and a means to operate the device by touching the appropriate icon. 
 
MAIN UPRIGHT OF BASE [7] 
The main upright of base supports the laser arm and contains the electrical connector [10] and 
the Locking Knob [11]. 
 
POWER INLET/FUSE HOLDER [8] 
The device contains an appliance coupler (Power Inlet) and a flexible detachable power cord.  
This is the location on the device where the power cord is connected.  NOTE:  The power cord 
must be plugged into the device at this location prior to plugging it into a wall socket.  The 
Power Inlet module also contains a fuse holder.  Replacing the fuses is the only service that can 
be conducted by the end-user.  
 
The device includes a transformer which converts AC input power to match the required DC 
power output.  Only a 3-prong power cord is required (Hospital Grade Only).  Once the power 
cord is affixed to the power inlet, the opposite end is plugged into a wall socket.  Input: 100-
240V~0.5-1.5A, 50-60 Hz. 
 
WHEEL LOCKS [9] 
The device includes four antistatic wheels that enable ease for maneuverability.  Once the 
device is transported to the desired location, the wheel locks can be engaged to eliminate 
excessive movement of the device. 
 

 
 
Erchonia Corporation Violet ZERONA® Z6 OTC Efficacy Study Protocol 
 
Version 1.0 
 
 
 
            Page 8    
 
 
March 22, 2022 
 
 
 
ELECTRICAL CONNECTOR [10] 
The electrical connector is a two-piece assembly.  The electrical connector connects the main 
head assembly to the base assembly to transfer data and power. 
 
LOCKING KNOB [11] 
The locking knob is utilized to secure the two-piece assembly [4] & [7], also preventing the laser 
arm assembly from unwanted rotation during use. 
 
POWER CORD [12] 
The device contains a hospital grade flexible detachable power cord.  The power cord plugs into 
the external power supply [13] prior to plugging the other end into a wall socket. 
 
 
 
EXTERNAL POWER SUPPLY [13] 
The power supply is an external AC/DC convertor that is required to power the device. The 
power supply must be plugged into the device power inlet (8) and the power cord (12), with the 
other end of the power cord plugged into a wall socket, to power the device. 
 
 
 
 
 
 
 
 
 
 
Protective Wear 
The Violet ZERONA® Z6 OTC is classified by the FDA/IEC as a Class 2 laser device. This 
represents a current standard for use to ensure the safety of the client. A Class 2 laser is 
determined to have a chronic viewing hazard. Pointing the laser beam directly into the eye and 
maintaining it there for an extended period could prove to be damaging.  
 
To ensure there is no possible instance of residual effect, we have included a pair of specialty 
glasses for use by the client during protocol. The Laser safety glasses sufficiently and effectively 
block the laser light spectrum at OD 2+ @ 635nm, OD 0.75 @ 405nm VLT60. 
 
Height: 40 mm 
Width: 145 mm 
Length: 165 mm 
 
 
 
 

 
 
Erchonia Corporation Violet ZERONA® Z6 OTC Efficacy Study Protocol 
 
Version 1.0 
 
 
 
            Page 9    
 
 
March 22, 2022 
 
 
 
Labeling 
The Violet ZERONA® Z6 OTC used in this clinical study is regulated as an investigational 
device, and as such, will be labeled as follows: 
 
 
 
 
 
 
Additionally, the diagrams below show the device labeling and their placement and is an excerpt 
from the Installation and Proper Use Reference Guide.  
 
The device is manufactured in accordance with the Good Manufacturing Practices set forth by 
the FDA, ISO Standards (International) and CE (Conformité Européenne or European 
Conformity) standards and testing results per Article 9.  The device is a Class I Shock 
Protection and a Class II Medical device.  Each of these governing agencies requires specific 
labeling.  All required labels are affixed according to the relevant codes.  Each label is pictured 
and described in this section.  Additionally, the placement of each label on the device is 
communicated.  
 
The following diagram shows the location of the power supply label, serial number label, power 
pushbutton label and one of the (2) identified pinch point labels. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CAUTION – Investigational Device. 
Limited by Federal (or United States) law to 
investigational use 

 
 
Erchonia Corporation Violet ZERONA® Z6 OTC Efficacy Study Protocol 
 
Version 1.0 
 
 
 
            Page 10   
 
 
 
March 22, 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
SAFETY 
 
Protective Wear 
 
The Violet ZERONA® Z6 OTC is classified by the FDA/IEC as a Class 2 laser device. This 
represents a current standard for use to ensure the safety of the client. A Class 2 laser is 
determined to have a chronic viewing hazard. Pointing the laser beam directly into the eye and 
maintaining it there for an extended period could prove to be damaging.  
 
To ensure there is no possible instance of residual effect, we have included a pair of specialty 
glasses for use by the client during protocol. The Laser safety glasses sufficiently and effectively 
block the laser light spectrum at OD 2+ @ 635nm, OD 0.75 @ 405nm VLT60. 
 
Height: 40 mm 
Width: 145 mm 
Length: 165 mm 
 
 
 
 
 
 
 
 
 
 
 

 
 
Erchonia Corporation Violet ZERONA® Z6 OTC Efficacy Study Protocol 
 
Version 1.0 
 
 
 
            Page 11   
 
 
 
March 22, 2022 
 
 
 
STUDY DESIGN 
 
This clinical study is an open-label single-arm non-inferiority design to evaluate the efficacy of 
the Erchonia Violet ZERONA® Z6 OTC in providing noninvasive body circumference reduction. 
As such, all enrolled subjects will receive the active study treatment, and therefore, neither 
randomization to procedure group nor blinding of the subjects nor investigative parties is  
applicable.  
 
STUDY BLINDING 
As all subjects in this study will receive the active procedure administration with the Erchonia 
Violet ZERONA® Z6 OTC, it is not possible to blind either subjects or investigators (device 
users).  
 
However, there are two aspects of this study design that assist in supporting elements of 
blinding: 
 
(i) The primary efficacy study outcome assessment of body circumference measurements is 
objective; and 
 
(ii) As the outcome data from this current study will be comparatively assessed to that of the 
active treatment group in the predicate device clinical study (the clinical data for the 
Zerona® Z6 OTC submitted in support of K143007), it is possible to blind the study 
statistician as to which data set pertains to which study, as the variables for each will be 
identical. The data from each study will be de-identified and presented to the study 
statistician simply as ‘Group A’ and ‘Group B’ data. The statistician will not be aware of 
which group – A or B – contains the current study data and which contains the comparative 
data. The study statistician will also not be made aware of sample sizes for either analysis 
group if there is a difference. In this way, study success analysis by the statistician cannot 
be biased. 
 
INVESTIGATORS / DEVICE USERS 
The respective investigator/device user sample population, defined as those who will be 
administering the treatments with the Erchonia Zerona® Violet Z6 OTC,  will be representative 
of the population of users (non-medical professionals) who may potentially purchase and 
operate the Violet ZERONA® Z6 OTC device following clearance. The respective investigators / 
device users will be the identical user population as that enrolled in the study evaluating efficacy 
and usability of the Zerona® Z6 OTC device in the 2014 comparative study (predicate) and for 
whom OTC market clearance of the device was subsequently attained through K143007.  
 
SUBJECTS  
 
The study sample population, defined as those who will be receiving the study treatments with 
the Erchonia Zerona® Violet Z6 OTC, will be identical to the study sample population as defined 
and enrolled in the reference study and as intended to be the real-world patient population 
recipients of the device treatments. 
 
Subject Sample 
Subjects will be males and females 18 years or older who are potential candidates for receiving 
the course of treatment using the Violet ZERONA® Z6 OTC device and who subsequently 
satisfy all criteria on the Client Qualification Checklist as verified by the device user.  
 

 
 
Erchonia Corporation Violet ZERONA® Z6 OTC Efficacy Study Protocol 
 
Version 1.0 
 
 
 
            Page 12   
 
 
 
March 22, 2022 
 
 
 
Sample Size 
There will be a minimum of 22 qualified subjects enrolled in and completing this study. 
 
Rationale for Sample Size 
Sample size is determined to be identical to the final sample size treated and evaluated in the 
2014 Zerona® Z6 OTC comparative study to enable clinically meaningful statistical comparison 
of outcomes to be performed. 
 
Recruitment 
Subjects will be recruited from among: 
(i) The test sites’ pool of existing and new clients 
(ii) Subjects who respond to the following IRB-approved recruitment materials: 
 
 
 
 
 
Compensation 
Subjects will not receive financial payment or any other form of compensation to participate in 
this study. Subject will not be charged for the cost of the Violet ZERONA® Z6 OTC treatments 
or for the cost of any other evaluations or measurements that occur as part of his or her 
participation in the study. 
 
 
 
 
 
 
 
 
 
 

 
 
Erchonia Corporation Violet ZERONA® Z6 OTC Efficacy Study Protocol 
 
Version 1.0 
 
 
 
            Page 13   
 
 
 
March 22, 2022 
 
 
 
STUDY PROCEDURES 
 
Investigators / device user in this clinical study will be required to follow all procedures 
contained within SECTION 3: VIOLET ZERONA Z6 OTC OPERATION of the Violet ZERONA® 
Z6 OTC Installation and Proper Use Reference Guide, pages 15 through 27, without any 
additional guidance, materials, instruction, whether verbal or written or otherwise, from any 
source, as per real-life intended use. 
 
SECTION 3 of the Violet ZERONA® Z6 OTC Installation and Proper Use Reference Guide 
includes the following: 
 
1. Violet ZERONA Z6 OTC Operation: pages 15 - 23 
2. Violet ZERONAT Z6 OTC Treatment Protocol: page 24 
3. Violet ZERONA Z6 OTC Client Qualification Checklist: pages 25 – 28: includes protocols 
for calculation of:  
- Body Mass Index (BMI): pages 26 - 27; and 
- Body circumference measurements (waist, hips, and thighs): page 28  
 
PRE-PROCEDURE ACTIVITIES 
 
All pre-procedure activities will take place on the same day and proceed successively as 
follows: 
 
SIGNING OF INFORMED CONSENT FORM 
The investigator / device user will commence by presenting and reviewing in detail the items in 
the informed consent form with the individual and answer any questions. To proceed further in 
the study protocol, the individual must willingly sign the informed consent form at this time. 
 
ASSIGNMENT OF SUBJECT ID 
The subject will be assigned a unique non-identifying Subject ID composed of the Investigator’s 
/ user’s first and last name initials and a 3-digit number based upon the subject’s order of entry 
into the study.  
 
INCLUSION/ EXCLUSION CATERIA 
The investigator / user conducts the CLIENT QUALIFICATION CHECKLIST as contained in the 
Installation and Proper Use Reference Guide, to determine if the client is suitable for the Violet 
ZERONA® Z6 OTC treatment. As part of this assessment, the investigator / user conducts the 
BMI evaluation. The CLIENT QUALIFICATION CHECKLIST includes PART A and PART B as 
follows: 
 
A. CLIENT QUESTIONS: The client will be asked to respond “YES or NO” to the following 
questions: 
 
- 
Are you under 18 years of age? 
- 
(Female clients only): Are you pregnant or do you think you might be pregnant? Not 
applicable, client is male 
- 
Do you have any open wounds (sores, cuts, ulcers, etc.)? 
- 
Do you have or are you being treated for any cancerous growths? 
 
A client that answers “YES” to one or more of the client questions is not suitable for the 
treatment with the Violet ZERONA® Z6 OTC. A client that answers “NO” to ALL the questions 
will proceed to the Body Mass Index (BMI) Calculation.  

 
 
Erchonia Corporation Violet ZERONA® Z6 OTC Efficacy Study Protocol 
 
Version 1.0 
 
 
 
            Page 14   
 
 
 
March 22, 2022 
 
 
 
B. BODY MASS INDEX (BMI) CALCULATION: 
- 
BMI is 30 or less => the client qualifies for Violet ZERONA Z6 OTC treatment.  
- 
BMI is more than 30 => the client does not qualify for Violet ZERONA Z6 OTC  
 
PRE-PROCEDURE STUDY MEASUREMENTS 
A subject who satisfies the criteria to receive the study treatment per the Client Qualification 
Checklist will complete the following pre-procedure study assessments: 
 
Circumference Measurements of the waist, hips, and thighs per the instructions contained in 
SECTION 3: VIOLET ZERONA® Z6 OTC OPERATION of the Installation and Proper Use 
Reference Guide, under the MEASUREMENT PROTOCOL & MEASUREMENT AREAS header 
on page 28.  
  
PROCEDURE ADMINISTRATION ACTIVITIES 
 
The procedure administration phase of the study will commence immediately following 
completion of the pre-procedure activities, on the same day. The first treatment administration 
with the Violet ZERONA® Z6 OTC will be administered that day. 
 
The investigator / device user is required to follow the instructions in SECTION 3: VIOLET 
ZERONA® Z6 OTC OPERATION of the Erchonia Violet ZERONA® Z6 OTC Installation and 
Proper Use Reference Guide to correctly administer a procedure. 
 
The procedure administration protocol in this current study is identical to that evaluated in the 
2014 comparative study, with the exception being that the treatment time with the violet laser is 
20 minutes compared to 40 minutes with the red laser. However, as the timing is automatically 
pre-programmed in the laser device, and it beeps and pauses automatically mid-treatment to 
enable the individual to turn-over and the laser arms to be resituated to the posterior aspect of 
the patient, and subsequently automatically shuts off when the second half of the treatment is 
completed, this has no impact on the user’s operation of the Violet ZERONA® Z6 OTC device 
compared with the ZERONA® Z6 OTC device. 
 
Both the predicate and the currently evaluated laser devices have the same treatment protocol: 
6 treatments occurring over 2 weeks: 3 treatments per week; each treatment every other day. 
 
PROCEDURE ASSESSMENTS 
 
After completion of the sixth and final scheduled Violet ZERONA® Z6 OTC treatment 
administration, the investigator / user will again record the subject’s BMI and waist, hips and 
thighs circumference following the protocols in the Installation and Proper Use Reference 
Guide.   
 
This is considered the study endpoint evaluation at which change relative to pre-procedure 
measurements will be assessed. Evaluation for and recording of any observed or reported 
adverse events will be conducted at each study visit. 
 
 
 
 
 

 
 
Erchonia Corporation Violet ZERONA® Z6 OTC Efficacy Study Protocol 
 
Version 1.0 
 
 
 
            Page 15   
 
 
 
March 22, 2022 
 
 
 
STATISTICAL ANALYSIS PLAN 
 
 
STUDY POPULATIONS 
The following two study populations will be evaluated: 
 
1. 
Modified Intent-to-Treat (mITT) Population  
 
Primary analysis of efficacy will be according to the modified intent to treat (ITT) analysis, 
including all enrolled subjects who had a valid baseline visit and received at least the first study 
treatment with the Erchonia Violet ZERONA® Z6 OTC.  
 
Missing data for the mITT population will be handled through Last Observation Carried Forward 
(LOCF) methodology. Sensitivity analysis may be applied if missing data is extensive. 
 
2. 
Per Protocol Population. 
 
Secondary analysis of efficacy to confirm the findings of the primary analysis will be conducted 
on the per protocol population, comprised of all subjects who completed the study per protocol 
through to the final treatment administration and outcomes measures recording visit. 
 
PRIMARY EFFICACY OUTCOME  
The primary efficacy outcome for this clinical study is the mean change in combined waist-hips-
bilateral thighs circumference measurement at study endpoint (following completion of the sixth 
and final treatment administration procedure) relative to baseline (pre-procedure). 
 
PRIMARY EFFICACY OUTCOME EVALUATION  
To determine primary efficacy outcome success, the mean change across all subjects enrolled 
in this study in combined waist-hips-bilateral thighs circumference measurements at study 
endpoint relative to baseline will be calculated and compared to the relative mean change 
attained for treated subjects in the reference study. 
 
As this study is a non-inferiority design, the research hypothesis is that violet diode therapy with 
the Erchonia Violet ZERONA® Z6 OTC is either equivalent to, or superior to, red diode therapy 
with the Erchonia Zerona® Z6 OTC in effecting a clinically meaningful reduction in body 
circumference. 
 
The selected equivalence margin (δ) is ±5%. Therefore, non-inferiority will be established if the 
mean change in combined circumference measurement for subjects treated with the violet diode 
laser in the current study is no more than 5% less than the subject group who received 
treatment with the red diode laser in the predicate reference trial that supported efficacy of the 
Zerona® Z6 OTC device (K143007). 
 
In the predicate reference study, the mean change in combined circumference measurements 
across the same 6-treatment 2-week evaluation period was a decrease of 3.72 inches. 
Therefore, success for the current study will be determined as having been met if the mean 
change in combined circumference measurements for the subject group in the current study is    
-3.72±5% inches (-3.53 to -3.91 inches). This is defined as the maximally clinically acceptable 
difference for which the range of efficacy values (±5%) are “close enough” to be considered 
equivalent. 

 
 
Erchonia Corporation Violet ZERONA® Z6 OTC Efficacy Study Protocol 
 
Version 1.0 
 
 
 
            Page 16   
 
 
 
March 22, 2022 
 
 
 
Hypotheses 
 
• Null Hypothesis: Treatment application of the Erchonia Violet ZERONA® Z6 OTC is inferior to 
treatment application of the Erchonia® Zerona® Z6 OTC in effecting a clinically meaningful 
reduction in body circumference. 
 
Hₒ: µ < -3.53 inches 
 
• Alternative Hypotheses: Treatment application of the Erchonia® Violet ZERONA® Z6 OTC is 
NOT inferior to treatment application of the Zerona® Z6 OTC in effecting a clinically meaningful 
reduction in body circumference. 
 
H1: µ ≥ -3.53 inches 
 
SUPPORTIVE SECONDARY EVALUATIONS  
 
The following two secondary evaluations will be performed to provide direct support for the 
primary efficacy evaluation outcome are will therefore be assessed with respect to statistical 
significance of change and/or against pre-determined non-inferiority success criteria. 
 
(i) T-test for independent samples will be performed to compare the mean change in combined 
circumference measurements across study evaluation (at endpoint relative to baseline) for 
subjects treated with the Violet ZERONA® Z6 OTC in the current study to the relative mean 
change for subjects treated with the ZERONA® Z6 OTC in the reference study treatment 
group. i.e., between device treatment groups. A finding of the difference being not 
statistically significant (p>0.05) will provide statistically significant and clinically meaningful 
support for the equivalency of the efficacy of the two devices. 
 
(ii) Responder rate analysis will be conducted wherein individual responder success is defined 
per the reference study as at least a 3.0-inch reduction (≥-3.0 inches) in combined 
circumference measurements for the waist, hips, and bilateral thighs from baseline to after 
study treatment completion. The maximally clinically acceptable difference for which the 
responder rate for the current study subject group is defined is (±5%), that is, 73% +/- 5% 
(68% - 78%), as the responder rate attained in the reference study was 73%. 
 
ADDITIONAL SECONDARY EFFICACY ANALYSIS  
 
Additional secondary efficacy analysis will comprise descriptive only presentation of the mean, 
standard deviation, and range of circumference measurements (inches) for each individual 
treatment area of the waist, hips, and right and left thighs, separately, at baseline, and endpoint, 
and the change between the two assessment points, in table format. As no additional claims are 
intended to be supported based on the additional secondary efficacy analysis, no statistical 
analysis of findings will be performed.  
 
INDIVIDUAL TEST SITE EFFICACY ANALYSIS 
 
Comparison of the primary efficacy outcome of mean change in combined waist-hips-bilateral 
thighs circumference measurements at study endpoint relative to baseline for subjects treated in 
the current study with the Violet Zerona® Z6 between each of the two study test sites will be 
conducted to support poolability of the study results. 
 

 
 
Erchonia Corporation Violet ZERONA® Z6 OTC Efficacy Study Protocol 
 
Version 1.0 
 
 
 
            Page 17   
 
 
 
March 22, 2022 
 
 
 
SAFETY ANALYSES 
 
Safety analyses will be based on all enrolled subjects and will be assessed by evaluating and 
comparing frequency and incidence of observed and/or reported adverse events between 
subjects who received treatments with the Erchonia Violet ZERONA® Z6 OTC in the current 
study and subjects who received treatments with the Erchonia ZERONA® Z6 OTC treatment in 
the predicate reference study. A chi-square test with a continuity correction will be performed to 
compare the percentage of subjects who had adverse events between the two subject groups. 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
APPENDIX B 
 
INFORMED CONSENT FORM 
 
 
 
 
 
 

Erchonia Corporation Violet ZERONA® Z6 OTC Informed Consent Forms 
 
Version 1.0 
Page 1 
March 22, 2022 
 
 
 
Subject ID:___________________ 
SUBJECT INFORMATION AND CONSENT FORM 
 
 
TITLE: 
An Evaluation of the Effect of the Erchonia 
Corporation Violet Zerona® Z6 for Body 
Contouring  
 
SPONSOR: 
Erchonia Corporation 
 
Melbourne, FL 
 
United States 
 
 
 
SITE(S): 
< > 
 
 
STUDY-RELATED 
PHONE NUMBER(S): 
<Investigator Name>. 
<Investigator phone> (24 hours) 

Erchonia Corporation Violet ZERONA® Z6 OTC Informed Consent Forms 
 
Version 1.0 
Page 2 
March 22, 2022 
 
 
 
Subject ID:___________________ 
This consent form may contain words that you do not understand. Please ask the 
study investigator to   explain any words or information that you do not clearly 
understand. You may take home an unsigned copy of this consent form to think 
about or discuss with family or friends before making your decision. 
 
SUMMARY 
 
You are being asked to be in a research study. The purpose of this consent form 
is to help you decide if you want to be in the research study. Please read this 
form carefully. To be in a research study you must give your informed consent.  
“Informed consent” includes: 
• Reading this consent form, 
• Having the study staff explain the research study to you, 
• Asking questions about anything that is not clear, and 
• Taking home an unsigned copy of this consent form. This gives you 
time to think about it and to talk to family or friends before you make 
your decision. 
 
You should not join this research study until all of your 
questions are answered. Things to know before deciding to 
take part in a research study: 
• The main goal of a research study is to learn things to help clients in the future. 
• The main goal of regular medical care is to help each client. 
• No one can promise that a research study will help you. 
• Taking part in a research study is entirely voluntary. No one can make you take part. 
• If you decide to take part, you can change your mind later on and 
withdraw from the research study. 
• The decision to join or not join the research study will not cause you to 
lose any medical benefits. If you decide not to take part in this study, 
your study doctor will continue to treat you. 
• This study involves use of a device that has been approved by the 
U.S. Food & Drug Administration (FDA) for this use. 
 
After reading and discussing the information in this consent form you should know: 
• Why this research study is being done; 
• What will happen during the research; 
• What device and procedures will be used; 
• Any possible benefits to you; 
• The possible risks to you; 
• The other medical procedures, drugs or devices that could be used 
instead of being in this research study; and 
• How problems will be treated during the study and after the study is over. 

Erchonia Corporation Violet ZERONA® Z6 OTC Informed Consent Forms 
 
Version 1.0 
Page 3 
March 22, 2022 
 
 
 
Subject ID:___________________ 
PURPOSE OF THE STUDY 
In this study, the Sponsor, Erchonia Corporation, is studying the use of a device called the 
Erchonia Violet Zerona® Z6 that gives off a low-level laser light. 
 
This study is to see if using the Violet Zerona® Z6 can help to reduce the circumference of 
the hips, waist, and thighs. Use of the Erchonia® Violet Zerona® Z6 in this study is 
investigational, as the Erchonia® Violet Zerona® Z6 has not been cleared for market by the 
U.S. Food and Drug Administration (FDA). 
PROCEDURES 
 If you agree to take part in this study, you will be one of about twenty-two (22) subjects 
taking part. 
 This is a test group only study. This means that if you choose to take part in this study, you 
will get the active (true) study treatment. 
 If you agree to take part in this study, you must also agree to not do any other treatments to 
try to change your body shape or to lose weight while in the study. This includes treatments 
such as over-the-counter or prescription medicines or supplements, weight loss programs and 
diet plans, surgical procedures, and alternative therapies like acupuncture or body wraps. 
 If you agree to take part in this study, you must also agree to maintain your usual diet and 
exercise patterns without any big changes while in the study. 
 The entire study takes about 2 weeks to complete. 
 The study visits are as follows: 
 
Screening Visit 
If you agree to take part in this research study, we will conduct a screening visit at the test 
site. At this visit, we will review this informed consent document. Then we will: 
 
• Measure your height and weight 
• Ask you a few simple questions 
This should take about 5 minutes. 
Pre-Study Treatment Phase 
The pre-study treatment phase will start once you have successfully completed the screening 
visit and we can confirm that you are eligible for this study, on the same day. At this time, we 
will measure around your hips, waist, and thighs using a flexible tape measure. 
 
This should take about 5 minutes. 
 
Study Treatment Phase 
 The study treatment phase will start right after the pre-study treatment phase is done 
 There are 6 study treatments with the study device in this study 
 The first study treatment will happen on the same day as the pre-study treatment phase 
 You will need to go to the test site again 5 more times over 2 weeks, every second day, 
for another study treatment 

Erchonia Corporation Violet ZERONA® Z6 OTC Informed Consent Forms 
 
Version 1.0 
Page 4 
March 22, 2022 
 
 
 
Subject ID:___________________ 
 
Each study treatment lasts 20 minutes 
 
You will lie on a study treatment table on your back for 10 minutes. The device arms 
will be placed around your body such that the laser light is centered on the middle of 
your body and shines on your stomach, the side of your waist, your hips and both upper 
thigh areas, but it will not touch your body 
 
Then you will turn over and lie on the study treatment table on your stomach for 
another 10 minutes. The device arms will be again placed around your body such that 
the laser light is centered on the middle of your back and shines on your lower back, 
sides of your waist, hips and upper thighs, but does not touch your body 
 
You will wear protective glasses to block out the laser light throughout the treatment 
process 
 
After the last study treatment, we will again measure your height and weight, and measure 
around your hips, waist, and thighs with a flexible tape measure as during the pre-treatment 
phase. 
This should take about 5 minutes. 
 
RISKS AND DISCOMFORTS 
 There have also been other research studies using Erchonia low level light lasers. In 
these studies, no serious medical events resulted from use of the device. 
 The only known or anticipated risk with the use of the laser device is that long-term 
exposure to laser light could cause damage to eyesight. As a precaution, when you are 
given the treatments with the Erchonia Violet Zerona® Z6, you will be fitted with 
special darkened protective glasses to block out the light. 
 However, there may be unknown risks to using the laser device with this study treatment 
such as skin irritation, discoloring, rash, indentations, and infection. There may be side 
effects that are not known at this time. 
 It is possible that you will not get any improvement in your body shape or that it may 
even get worse. 
 
PREGNANCY 
Women who are pregnant may not take part in this study. If you are trying to get pregnant, 
you should not volunteer for this study. Before entering the study, you must agree on the 
method of birth control you will use during the entire study. If you think that you have 
gotten pregnant during the study, you must tell the study investigator immediately. 
Pregnant women will be taken out of the study. 
 
NEW INFORMATION 
You will be told about any new information that might change your decision to be in this 
study. You may be asked to sign a new consent form if this occurs. 
 
BENEFITS 
The shape of your hips, waist, and thighs may improve while you are in this study; 

Erchonia Corporation Violet ZERONA® Z6 OTC Informed Consent Forms 
 
Version 1.0 
Page 5 
March 22, 2022 
 
 
 
Subject ID:___________________ 
however, this cannot be promised. The results of this study may help Erchonia Corporation, 
the manufacturer of the Violet Zerona® Z6 device to market and sell the device to lay (non-
medical professional) people to help others improve the shapes of their bodies in the future. 
 
COSTS 
It will not cost you anything to be part of the study. Erchonia Corporation, the sponsor of 
this research will provide the treatments with the Erchonia Violet Zerona® Z6 free of 
charge during this study. The cost for all study related procedures and measurements will 
also be covered by Erchonia Corporation. Nothing will be billed to you or to your insurance 
company. 
PAYMENT FOR PARTICIPATION 
You will not be paid for your part in this research study. 
ALTERNATIVE TREATMENT 
If you decide not to enter this study, there is other care available to you, such as over-the-
counter and prescription medications such as Xenical Meridia and Alli; diet and exercise 
programs such as Weight Watchers, LA Weight Loss, SlimFast, and Atkin’s; surgical 
procedures such as liposuction, abdominoplasty, stomach stapling and lap bands; and 
alternative therapies such as acupuncture, body wraps, hypnotherapy and mesotherapy. 
Your doctor can discuss these with you if you like. You do not have to be in this study to 
be treated for improving your body shape. 
 
AUTHORIZATION TO USE AND DISCLOSE INFORMATION FOR 
RESEARCH PURPOSES 
What information may be used and given to others? 
The study investigator will get your personal and medical information. For example: 
• Research records 
• Records about your study visits 
Who may use and give out information about you? 
The study investigator and the study staff 
Who might get this information? 
The sponsor of this research. “Sponsor” means any persons or companies that are: 
• working for or with the sponsor, or 
• owned by the sponsor. 
Your information may be given to: 
• The U.S. Food and Drug Administration (FDA), 
• Department of Health and Human Services (DHHS) agencies, 
• Governmental agencies in other countries, 
• Western Institutional Review Board® (WIRB®) 
• A description of this clinical trial will be available on www.clinicaltrials.gov, as 
required by U.S. Law. This Web site will not include information that can identify 

Erchonia Corporation Violet ZERONA® Z6 OTC Informed Consent Forms 
 
Version 1.0 
Page 6 
March 22, 2022 
 
 
 
Subject ID:___________________ 
you. At most, the Web site will include a summary of the results. You can search 
this Web site at any time. 
 
Why will this information be used and/or given to others? 
• to do the research, 
• to study the results, and 
• to see if the research was done right. 
If the results of this study are made public, information that identifies you will not be used. 
 
What if I decide not to give permission to use and give out my health information? 
Then you will not be able to be in this research study. 
 
May I review or copy my information? 
Yes, but only after the research is over. 
 
May I withdraw or revoke (cancel) my permission? 
Yes, but this permission will not stop automatically. 
 
You may withdraw or take away your permission to use and disclose your health 
information at any time. You do this by sending written notice to the study investigator. If 
you withdraw your permission, you will not be able to stay in this study. 
 
When you withdraw your permission, no new health information identifying you will be 
gathered after that date. Information that has already been gathered may still be used and 
given to others. 
 
Is my health information protected after it has been given to others? 
There is a risk that your information will be given to others without your permission. 
 
COMPENSATION FOR INJURY 
If you are injured or get sick as a result of being in this study, call the study investigator 
immediately. The study investigator will provide emergency medical treatment. Your 
insurance will be billed for this treatment. The sponsor will pay any charges that your 
insurance does not cover. No other payment is routinely available from the study 
investigator or sponsor. 
 
VOLUNTARY PARTICIPATION AND WITHDRAWAL 
Your participation in this study is voluntary. You may decide not to participate, or you may 
leave the study, at any time. Your decision will not result in any penalty or loss of benefits 
to which you are otherwise entitled. 
 
Your participation in this study may be stopped at any time by the study investigator or the 
sponsor without your consent for any of the following reasons: 
• if it is in your best interest; 
• you do not consent to continue in the study after being told of changes in the research that 
may affect you; 

Erchonia Corporation Violet ZERONA® Z6 OTC Informed Consent Forms 
 
Version 1.0 
Page 7 
March 22, 2022 
 
 
 
Subject ID:___________________ 
• or for any other reason. 
SOURCE OF FUNDING FOR THE STUDY 
The sponsor, Erchonia Corporation, will pay for this research study. 
 
QUESTIONS 
Contact (Investigator) at (telephone number) (24 hours) for any of the following reasons: 
• if you have any questions about this study or your part in it,   
• if you feel you have had a research-related injury or a bad reaction to the study treatment, or 
• if you have questions, concerns, or complaints about the research. 
 
If you have questions about your rights as a research subject or if you have questions, 
concerns, or complaints about the research, you may contact: 
 
WCG IRB 
1019 39th Avenue SE Suite 120 
Puyallup, Washington 98374-2115 
Telephone:  855-818-2289 
E-mail: researchquestions@wcgirb.com 
 
The IRB is a group of people who independently review research. 
 
The IRB will not be able to answer some study-specific questions, such as questions about 
appointment times.  However, you may contact the IRB if the research staff cannot be reached or 
if you wish to talk to someone other than the research staff.  
 
Do not sign this consent form unless you have had a chance to ask questions and have gotten 
satisfactory answers. 
 
If you agree to be in this study, you will receive a signed and dated electronic copy of this consent 
form for your records. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Erchonia Corporation Violet ZERONA® Z6 OTC Informed Consent Forms 
 
Version 1.0 
Page 8 
March 22, 2022 
 
 
 
Subject ID:___________________ 
 
CONSENT 
I have read this consent form. All my questions about the study and my part in it have been 
answered. I freely consent to be in this research study. 
 
I authorize the use and disclosure of my health information to the parties listed in the 
authorization  section of this consent for the purposes described above. 
 
By signing this consent form, I have not given up any of my legal rights. 
 
 
  
Subject Name (printed) 
 
 
 
 
 
CONSENT SIGNATURE: 
 
 
Signature of Subject (18 years and older) 
 
Date 
 
 
Signature of Person Conducting Informed 
 
Date 
Consent Discussion