An Evaluation of the Effect of the Erchonia Corporation CFL Laser for Non-invasive Reduction of Submental Fat
Conditions: Weight Loss
Sponsor: Erchonia Corporation

 
 
 
 
 
 
ERCHONIA® CORPORATION CFL 
 
 
 
An Evaluation of the Effect of the Erchonia 
Corporation CFL Laser for non-invasive 
reduction of submental fat 
 
 
NCT05954065 
 
 
 
Version 1.0 
April 20, 2023 

Erchonia Corporation CFL Efficacy Study Protocol 
Version 1.0 
April 20, 2023 
 
 
Table of Contents 
     
STUDY INFORMATION ..........................................................................................................1 
PURPOSE OF STUDY ............................................................................................................2 
INDICATION FOR USE ...........................................................................................................2 
EXPECTED RESULTS ............................................................................................................2 
REGULATORY BACKGROUND AND JUSTIFICATION FOR THE CURRENT STUDY ..........2 
STUDY DEVICE ......................................................................................................................4 
SAFETY ..................................................................................................................................8 
PROTECTIVE WEAR ..............................................................................................................8 
THEORY OF MECHANISM OF OPERATION OF THE APPLICATION OF ERCHONIA® 
LASERS FOR NON-INVASIVE FAT LOSS .............................................................................8 
SUPPORTING BIOLOGICAL DATA.........................................................................................9 
SUPPORTING CLINICAL DATA: ERCHONIA CORPORATION CLINICAL TRIAL RESULTS ..9 
STUDY DESIGN ...................................................................................................................16 
SUBJECTS............................................................................................................................16 
STUDY DESIGN ...................................................................................................................19 
STUDY PROCEDURE ..........................................................................................................20 
STUDY TEST BATTERY .......................................................................................................20 
STUDY PROCEDURES ........................................................................................................21 
PRE-TREATMENT  ACTIVITIES ...........................................................................................21 
PRE-TREATMENT EVALUATIONS ......................................................................................22 
TREATMENT ADMINISTRATION PHASE ............................................................................23 
TREATMENT ADMINISTRATION PROTOCOL ....................................................................23 
ADVERSE EVENTS ..............................................................................................................24 
PRIVACY AND CONFIDENTIALITY ......................................................................................24 
STATISTICAL ANALYSIS PLAN ...........................................................................................25 
INFORMED CONSENT .........................................................................................................28 
CASE REPORT FORMS .......................................................................................................28 
 
APPENDICES 
APPENDIX A: LETTER OF APPLICATION FOR NON-
SIGNIFICANT RISK (NSR) DETERMINATION 
APPENDIX B: PHOTOGRAPH METHODOLOGY INSTRUCTION SHEET 
 APPENDIX C: RECRUITMENT ADVERTISEMENTS 
APPENDIX D: INFORMED CONSENT FORM  
APPENDIX E: CASE REPORT FORMS  

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STUDY INFORMATION 
 
SPONSOR 
Erchonia Corporation 
112 Southchase Blvd.  
Fountain Inn, SC 29644 
Contact: Travis Sammons 
Telephone: 888-242-0571 ext. 7510 
E-mail: tsammons@erchonia.com 
www.erchonia.com 
 
  
REGULATORY AND CLINICAL CONSULTANT 
Elvira Cawthon, Principal Consultant 
219 East Harbor 
Hendersonville, TN 37075 
Telephone: 615-879-9875 
E-mail: cawthonconsulting@outlook.com 
 
MONITOR 
Erchonia Corporation 
112 Southchase Blvd.  
Fountain Inn, SC 29644 
 
Contact: Travis Sammons 
Telephone: 888-242-0571 ext. 7510 
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 
IRB Tracking Number: 20232933 
 
E-mail: clientcare@wcgclinical.com 
 
www.wcgclinical.com 
 
PRINCIPAL CLINICAL INVESTIGATORS AND TEST SITES 
Dr. Michael Williams, D.O. 
3023 Winghaven Blvd. 
O’Fallon, MO 63368 
Telephone: 636.333.9820 
E-mail: mwilliams@ultrawellnessmedical.com 
 
Dr. Spencer Franchi, DO 
2250 US Hwy 41 
Marquette, MI 49855 
Telephone: 906.360.9774 
E-mail: spencer.franchi@gmail.com 
 
 
 
 

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PURPOSE OF STUDY 
The purpose of this clinical study is to determine the effectiveness of the Erchonia® CFL 
(manufactured by Erchonia Corporation (the Company), in providing noninvasive fat reduction 
in the submental area.  
 
STUDY DURATION 
The estimated total duration of the study is 16 weeks. 
 
INDICATION FOR USE 
The indication (claim) being sought through support of the results of this clinical study is:  
 
“The Erchonia CFL is indicated to affect the appearance of visible fat bulges in the submental 
area”. 
 
The indication for use of the Erchonia CFL is identical to Coolsculpting System (K151179) and 
SculpSure (K171992) which have obtained FDA market to “affect the appearance of visible fat 
bulges in the submental area”. It is intended that the results of this clinical study be used to 
support a 510(k) submission for FDA market clearance. 
 
EXPECTED RESULTS 
Twelve weeks post-final treatment, it is anticipated that compared with pre-treatment, subjects 
will demonstrate a reduction in the appearance of submental fat. An Individual subject is defined 
as a “study responder” if at least 2 of the 3 Independent Blinded Evaluators correctly identify the 
subject’s post-treatment photograph, with overall study success defined as a minimum 
responder rate of 80%.   
 
The Week 16 12-week post-final treatment primary endpoint evaluation is identical to that 
employed in the clinical trials whose results supported the above-referenced FDA market 
cleared devices; Coolsculpting System (K151179) and SculpSure (K171992). 
 
REGULATORY BACKGROUND AND JUSTIFICATION FOR THE CURRENT STUDY 
 
BACKGROUND 
Erchonia Corporation (manufacturer of the CFL Laser) has extensive regulatory background 
with the Food and Drug Administration (FDA) in non-invasive fat loss indications, under FDA 
product code OLI. Each of the below respective market clearances was supported by efficacy 
data from a full-scale controlled and powered clinical trial conducted by Erchonia Corporation. 
 
• 
K150446: The Erchonia® Zerona 6 Headed Scanner (EZ6) device is indicated for use as a 
non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, 
waist, thighs and upper abdomen when applied to individuals with a Body Mass Index (BMI) 
between 25 kg/m² and 40 kg/m². 
 
• 
K143007: The Zerona® Z6 OTC device is indicated for use as a non-invasive 
dermatological aesthetic treatment for the reduction of circumference of hips, waist and 
thighs. 
 
• 
K142042: The Erchonia® SHL Laser is indicated for use as a non-invasive dermatological 
aesthetic treatment for reduction of circumference of hips, waist and upper abdomen when 
applied to individuals with a Body Mass Index (BMI) between 30 kg/m² and 40 kg/m². 
 
• 
K123237 & K133718: The Erchonia® Zerona™ 2.0 Laser & Zerona®-Z6 device is indicated 
for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals 

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intending to undergo liposuction procedures for the reduction of circumference of hips, 
waist, and thighs. 
 
• 
K121695 & K082609: The Erchonia® ML Scanner (MLS) & Erchonia® Zerona device is 
indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for 
individuals intending to undergo liposuction procedures for the reduction of circumference of 
hips, waist, and thighs. 
 
• 
K121690 & K120257: The Erchonia® MLS, Zerona, Zerona-AD Laser is indicated for use 
as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending 
to undergo liposuction procedures for the reduction of circumference of the upper arms. 
 
Each of these market clearances falls under FDA Product Code OLI, defined as follows: 
 
Device 
Fat Reducing Low Level Laser 
Regulation Description 
Low level laser system for aesthetic use 
Definition 
Non-invasive reduction in fat layer for body contouring 
Physical State 
laser system that emits laser energy in the red spectrum 
Technical Method 
use of low level laser energy to create pores in adipocyte cells 
to release lipoproteins 
Target Method 
adipocyte cells within the fat layer of the body, this could include 
waist, thighs, abdomen, hips, etc... 
Device Class 
2 
 
 
GENERALIZED INDICATION FOR “REDUCTION OF BODY CIRCUMFERENCE” 
Erchonia Corporation has demonstrated efficacy in the application of low-level lasers for non-
invasive fat loss in the body areas of the thighs, hips, waist, upper abdomen, and upper arms. 
Based on Erchonia Corporation’s collection of clinical data that demonstrated the 
generalizability of the therapeutic effects of the Erchonia LLLT across all body areas with no 
change in the anticipated efficacy outcome or safety profile, the FDA granted Erchonia 
Corporation low level laser devices a generalized indication for “Reduction of body 
circumference” under K192544, K220519, K162578. 
 
While Erchonia corporation has obtained an FDA market clearance for generalized reduction 
of overall body circumference, it is intended that the results of the current proposed trial will 
support a specific indication “to affect the appearance of visible fat bulges in the submental 
area”. 
 
 
 
 
 
 
 
 
 
 
 
 
 

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STUDY DEVICE 
 
DEVICE DESCRIPTION 
The Erchonia® CFL Laser is designed for clients seeking noninvasive fat loss of the submental 
(chin) area without invasive surgery. The CFL Laser allows the patient to continue their daily 
activities without interruptions from surgery, pain, wounds or garments. The CFL 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 CFL Laser was built on 
the clinical foundation of its predecessors, Zerona® and Zerona®-AD, and ZERONA® Z6 OTC, 
Verju, Emerald which were proven through clinical studies that supported clearances for said 
devices and respective indications for use to be safe and effective in the application of 
noninvasive fat loss. 
 
The Erchonia® CFL Laser used in this study is a handheld low-level laser that uses two semi-
conductor diodes; a 520 nanometer and a 405 nanometer, each emits its wavelength with a 
tolerance of ±10 nanometer. The lasers are powered by an internal battery that is recharged 
using a separate inductive charging base powered by an external class II medical power supply. 
This configuration offers portability as well as consistency of power. The internal battery powers 
the two specially created and patented electronic diodes with an output of 7.5mW (± .50 mW) 
for both the green and violet laser. The device contains software that is embedded in a RAM 
chip on the PCB. This data includes the touch screen images (GUI) and the command prompts 
that activate the screen icons; work in conjunction with the component platform to ensure the 
device operates as intended.  
 
The Erchonia® CFL has the following specifications: 
Device 
• 
Weight: Laser-.66lbs / .30kgs. Charger Base-.60lbs / .27kgs 
• 
Full Color TFT Touch Screen Module 
• 
Machined billet aluminum enclosure 
• 
Dimensions: Laser-Length-6.8” (17.27cm) Width-3.10” (7.87cm) Depth-.75” (1.90cm), 
 
Laser 
• 
2 electronic diodes, with patented optics 
• 
Output: 520 nm 7.5mW ± .50mW (green) 
• 
Output: 405 nm 7.5mW ± .50mW (violet) 
• 
Wavelengths: 520 nm & 405nm ± 10nm 
 
Power 
• 
Battery: Lithium-ion Polymer 3.7V, ≤3000mAh, 6.7W 
 
Inductive Charging Base 
• 
1.2A 15V 
 
External Power Supply 
• 
Model: ER-E-00375 
• 
100-240Vac, 47-63Hz, 0.5A; 15Vdc 1.2A 
• 
100-240Vac, 50-60Hz, 0.5A; 12Vdc 1.5A 
 
The following diagram identifies each component of the device, and a complete description of 
the component follows. 

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#1 POWER BUTTON WITH LED (ON/OFF) 
The Power Button allows the user to turn the device ON “|” or OFF “O”. To turn the device ON, 
the user presses and releasees this button so that the blue power LED turns on. To turn off the 
device, it is recommended to use the “Power Down” icon.  
 
#2 TOUCH SCREEN 
The touch screen functions as a display screen and an input panel, providing information and a 
means to operate the device by touching the appropriate icon. 
 
CAUTION - DO NOT use sharp objects such as a pencil point or ballpoint pen to select the 
icons on the touch screen as damage may result. Avoid using abrasives (including paper 
towels) on the touch screen display window. 
 
#3 PIVOTING LASER MOUNT 
The Pivoting Laser Mount allows the user to adjust the laser angle 90 º in one direction and 45 º 
in the other direction, based on user preference. 
 
#4 LASER DIODES 
The device consists of two electronic laser diodes, with patented optics. These laser diodes 
when activated by the internal power source generate laser energy thereby emitting on one side 
a green beam and the other side a violet beam. This is a specially designed and patented 
device created to ensure the laser beam is focused and directed for the most optimal use.  
 
 
 

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#1 INDUCTIVE CHARGER BASE 
The Inductive Charger Base is a custom based system specifically designed to charge the laser 
device. It is an inductive charging system that charges the device wirelessly. The Charger Base 
must be connected to the power supply and the power supply must be plugged into a wall 
socket for the Charger Base to receive power. Once powered up, the laser device is placed on 
the Charger Base with the touch screen facing up and the Laser diodes facing away from the 
Charger Base LED lights. The Charger Base can also be placed in a folded position if preferred 
by pushing the Charger Base dock down towards the base. 
 
NOTE: The lasers do NOT operate when the handheld device is in the charger base. 
 
#2 CHARGER BASE POWER LIGHT 
The Charger Base “Power” Light is the power indicator LED that will light up when the energized 
Power Supply connector is plugged into the Inductive Charger Base. 
 
#3 DOCKED LIGHT 
The “Docked” light is an indicator LED that will light up to indicate the device is correctly docked 
in the inductive charger base. The LED will flash ON and OFF when correctly in place and turn 
off when removed from the inductive Charger Base. 
 
#4 CHARGER BASE CONNECTOR PORT 
The Charger Base Connector Port is the location to plug the [#5] Power Supply Connector in to 
supply power to the inductive Charger Base. 
 
#5 POWER SUPPLY CONNECTOR 
The Power Supply Connector plugs into the Inductive Charger Base Connector Port to provide 
power to charger base. The Power Supply comes with a detachable power supply cord [#6] that 
must be plugged into the Power Supply and a wall socket in order to charge. 

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This device should be operated in temperatures between 59 to 85°F (15 to 29°C) <50% relative 
humidity and transported in temperatures between 14 to 140°F (-10 to 60°C) relative humidity 
<95%. 
 
#6 DETACHABLE POWER SUPPLY CORD 
The detachable power supply cord plugs directly into the power supply connector [#5] and into a 
wall socket in order for the power supply to operate. 
 
LABELING 
The Erchonia® CFL to be used in this clinical study will be labeled, “CAUTION – 
Investigational device.  Limited by United States law to investigational use.”  Once the 
device has been cleared for market in the U.S., the device will be labeled as a prescription 
device, per 21 CFR § 801.109. 
 
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 compliance issues have been combined into one series of labels located on the back of the 
device and an output label alongside the probe. The following diagram shows the placement of 
the compliance information and an enlarged label on which it is printed. 
 
 
 
 
 
 

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SAFETY 
 
PROTECTIVE WEAR 
The Erchonia® CFL is classified by the FDA/IEC as a Class 2 laser device. This designation 
represents a current standard for use in order to ensure the safety of the patient. 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 of time 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 patient during treatment. The safety glasses sufficiently and effectively block the 
laser light spectrum at OD 7+ @ 180-532nm, OD 0.75 @ 405nm VLT60. 
• Length: 144 mm 
• Width: 145 mm 
• Height: 50 mm 
 
 
 
 
 
 
 
 
WARNING- The patient should always be correctly fitted with the safety glasses 
provided before turning on the laser and doing any treatment. 
 
 
THEORY OF MECHANISM OF OPERATION OF THE APPLICATION OF ERCHONIA® 
LASERS FOR NON-INVASIVE FAT LOSS 
 
The theory of mechanism of operation of the application of Erchonia® low level lasers for non-
invasive fat loss has been well-established, proven and accepted. 
 
Erchonia Corporation light laser devices have been cleared by the FDA under Product Code 
‘OLI’. Under 21 CFR 878,5400, FDA identifies this generic type of device as: “A Low Level 
Laser System for Aesthetic Use is a device using low level laser energy for the disruption of 
adipocyte cells within the fat layer for the release of fat and lipids from these cells for non-
invasive aesthetic use.” 
 
This determination is supported by the results of a study performed by Dr. Neira using Erchonia 
diode lasers, wherein it was found using electron microscopy that a transitory pore in the 
adipocyte cell membrane formed following irradiation with the Erchonia laser diode. The 
formation of the transitory pore allowed for fat to pass from the intracellular space into the extra-
cellular space. Dr. Neira’s research was subsequently reaffirmed by Dr. Susan Lim using 
Standard and Cryo Scanning Electron Micrographs, in which she demonstrated the formation of 
the transitory pore as well as the movement of fat droplets across the membrane. 
 
Therefore, the biochemical effect of Erchonia® low level laser light therapy devices stimulate the 
mitochondria of the adipocyte cells which in turn increases the production of ATP. The newly 
synthesized ATP triggers the up-regulation of cyclic adenosine monophosphate (cAMP). cAMP 
has been shown to stimulate cytoplasmic lipase, triggering the conversion of triglycerides into 
fatty acids and glycerol that can easily pass through the cell membrane. The transitory pore is 

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evidence that the laser is allowing for the movement of fatty acids, glycerol, and triglycerides to 
pass across the membrane and into extra- cellular space. Through vasodilation of nearby blood 
vessels and arteries, oxidization of the triglycerides and fatty acids occurs within the extra-
cellular space. 
 
SUPPORTING BIOLOGICAL DATA 
 
The following abstract support the theory of adipose tissue liquefaction for the purpose of body 
contouring 
 
Fat Liquefaction: Effect of Low-Level Laser Energy on Adipose Tissue. 
Plastic & Reconstructive Surgery. 110(3):912-922, September 1, 2002. 
Neira, Rodrigo M.D.; Arroyave, Jose B.S.C.E., T.E.M., S.E.M.; Ramirez, Hugo M.V.; Ortiz, Clara 
Lucia M.D.; Solarte, Efrain Dr. rer. nat.; Sequeda, Federico Ph.D.; Gutierrez, Maria Isabel M.D., 
M.Sc., Ph.D. 
 
Low level laser energy has been increasingly used in the treatment of a broad range of 
conditions and has improved wound healing, reduced edema, and relieved pain of various 
etiologies. This study examined whether 635 nm low level lasers had an effect on adipose 
tissue in vivo and the procedural implementation of lipoplasty/liposuction techniques. The 
experiment investigated the effect of 635 nm, 10 mW diode laser radiation with exclusive energy 
dispersing optics. Total energy values of 1.2 J/cm2, 2.4 J/cm2, and 3.6 J/cm2 were applied on 
human adipose tissue taken from lipectomy samples of 12 healthy women. The tissue samples 
were irradiated for 0, 2, 4, and 6 minutes with and without tumescent solution and were studied 
using the protocols of transmission electron microscopy and scanning electron microscopy. 
Non-irradiated tissue samples were taken for reference. More than 180 images were recorded 
and professionally evaluated. All microscopic results showed that without laser exposure the 
normal adipose tissue appeared as a grape-shaped node. After 4 minutes of laser exposure, 80 
percent of the fat was released from the adipose cells; at 6 minutes of laser exposure, 99 
percent of the fat was released from the adipocyte. The released fat was collected in the 
interstitial space. Transmission electron microscopic images of the adipose tissue taken at x 
60,000 showed a transitory pore and complete deflation of the adipocytes. The low level laser 
energy affected the adipose cell by causing a transitory pore in the cell membrane to open, 
which permitted the fat content to go from inside to outside the cell. The cells in the interstitial 
space and the capillaries remained intact. Low level laser-assisted lipoplasty has a significant 
impact on the procedural implementation of lipoplasty techniques. 
 
SUPPORTING CLINICAL DATA: ERCHONIA CORPORATION CLINICAL TRIAL RESULTS 
 
The following are summaries of the results of the clinical trials performed and submitted in 
support of the FDA clearances for the body contouring/fat reduction indications as reported 
above (K142042, K121695, K082609, K121690, K120257, K123237). 
 
An Evaluation of the effectiveness of the Erchonia® Scanner device (GLS) as a non- 
invasive dermatological aesthetic treatment for the reduction of circumference of the 
waist, hips and thighs; Version 2.0, March 24, 2011 (cleared and marketed as the 
Erchonia® Zerona™ 2.0 Laser) 
 
PURPOSE OF STUDY 
The purpose of this clinical study was to determine the effectiveness of the Erchonia® Scanner 
device (GLS) for non-invasive body contouring of the waist, hips and bilateral thighs by applying 

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green diode (532 nm) energy around the waist, hips and thighs for 30 minutes, six times across 
two weeks, at the investigator’s test site. 
 
DEVICE DESCRIPTION 
The Erchonia® Scanner device (GLS) used in this study employed 532 nm green laser diodes. 
 
STUDY DESIGN 
The study was a placebo-controlled, randomized, double-blind parallel group design conducted 
across two independent test sites. 
 
STUDY SUBJECT POPULATION 
Sixty seven (67) subjects completed this study. Of the 67 participating subjects, 35 were 
randomized to the active procedure group and 32 were randomized to the placebo group. 
 
Study subject age ranged from 20 to 63 years and averaged 38 years (n=49). Forty-six (46) 
subjects (84%) were female and 9 subjects were male (16%). Fifty-six (56) subjects (92%) were 
Caucasian, 3 subjects (5%) were Middle Eastern, and 2 subjects (3%) were African American. 
 
PROCEDURE ADMINISTRATION 
Subjects received six procedure administrations with the Erchonia® Scanner device (GLS) 
(active or sham) across a consecutive two-week period: three procedures per week, each 
procedure two to three days apart. For each procedure administration, exposure time to the 
Erchonia® GLS was 15 minutes across the frontal region and 15 minutes across the lateral 
region. 
 
STUDY MEASURES 
Circumference measurements (inches) of the waist, hips, right thigh and left thigh were 
recorded at baseline, study mid-point (week 1), study endpoint (week 2), and study follow-up 
two weeks later. Subject satisfaction with procedure outcome was recorded at study endpoint. 
 
STATISTICAL ANALYSIS 
Primary Efficacy Outcome Analysis 
The study primary outcome measure was defined as the change in total combined inches in 
circumference measurements (waist, hips and bilateral thighs) from baseline (pre-procedure) to 
following completion of the two-week procedure administration phase (study endpoint: end of 
week 2). 
 
INDIVIDUAL SUBJECT SUCCESS CRITERIA 
It was pre-determined that a subject would be considered a study success if he or she attained 
a 3.0 inch or greater reduction in total combined inches in circumference measurements across 
this primary evaluation period. 
 
OVERALL STUDY SUCCESS CRITERIA 
It was pre-determined that the study would be considered an overall success if the proportion of 
individual subject successes in the test (active procedure) group was at least 35% greater than 
the proportion of individual subject successes in the placebo (sham procedure) group. 
 
68.57% of subjects who received the study procedures with the actual (active) Erchonia® GLS 
attained a decrease in combined circumference measurements of 3.0 inches or greater 
compared with 18.75% of subjects who received the study procedures with a ‘fake’ (placebo) 
laser device. A Fischer’s Exact Test for two independent proportions found this difference of 

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49.82% between subject procedure groups to be statistically significant at p<0.0001. 
 
CHANGE SCORES 
The mean change in combined circumference measurement for subjects who received the 
study procedures with the actual (active) Erchonia® GLS was a decrease of 3.895 inches, while 
the mean change in combined circumference measurements for subjects who received the 
study procedures with the ‘fake’ (placebo) laser device was a decrease of 1.135 inches. A t-test 
for two independent samples found the mean change in combined circumference 
measurements from baseline to study endpoint for test (active procedure) group subjects to be 
significantly greater than that for placebo (sham procedure) group subjects, at p<0.0001. 
 
Table 13 and Chart 1 below show the mean change in combined circumference measurements 
(waist, hips, and right and left thigh circumference measurements combined) across the four 
study measurement time points for the intent-to-treat (ITT) study subject population. 
 
 
Table 1: Mean total circumference 
 
Chart 1: Mean change in total circumference 
measurements (ins.) across evaluation points 
 
measurements (ins.) at each study. 
evaluation point relative to baseline. 
 
 
 
For test group subjects, combined circumference measurements decreased progressively and 
significantly from baseline through post-procedure evaluation, indicating a progressive and 
cumulative treatment effect of the laser that prevailed for at least 2 weeks following the end of 
the laser procedure administration period. Total circumference measurements for placebo group 
subjects did not change significantly across the same evaluation period. 
 
STUDY OUTCOME SATISFACTION RATINGS 
At completion of the study procedure administration phase, the subject was asked to rate how 
satisfied he or she was with any overall change in the appearance of the waist-hips-bilateral 
thighs area attained using the following five-point scale: Very Satisfied; Somewhat Satisfied; 
Neither Satisfied nor Dissatisfied; Not Very Satisfied; Not at All Satisfied. Sixty-five percent 
(65%) of test group subjects reported being ‘Satisfied’ (‘Very Satisfied’ or ‘Somewhat Satisfied’) 
with the outcome of the study procedures compared with 19% of placebo subjects. 
 
ADVERSE EVENTS 
No adverse event occurred for any subject throughout the duration of the clinical study. There 
was no change in skin markers in the treated body areas, and no notable deviation from 
baseline diet, exercise or concomitant medication use for any study subject. 
 
 
Test 
Group 
Placebo 
Group 
Baseline 
119.97 
117.04 
Midpoint (week 1) 
117.03 
116.41 
Endpoint (week 2) 
116.08 
115.91 
Follow-up (week 4) 
115.86 
115.72 

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An Evaluation of the effectiveness of the Erchonia® ML Scanner (MLS) as a non- invasive 
dermatological aesthetic treatment for the reduction of circumference of the upper arms; 
Version 1.1; January 4, 2011 
 
PURPOSE OF STUDY 
The purpose of this clinical study was to demonstrate the effectiveness of the Erchonia® ML 
Scanner (MLS) for non-invasive body contouring of the upper arms by applying the MLS to the 
upper arms six times across two weeks. 
 
DEVICE DESCRIPTION 
The Erchonia® MLS laser device used in this study employed 635nm red laser diodes. 
 
STUDY DESIGN 
The study was a placebo-controlled, randomized, double-blind parallel group design conducted 
across two independent test sites. 
 
STUDY SUBJECT POPULATION 
Sixty two (62) subjects completed this study. Of the 62 participating subjects, 31 were 
randomized to the active procedure group and 31 were randomized to the placebo group. 
 
Sixty (60) subjects (97%) were female and 2 subjects were male (3%). Thirty seven (37) 
subjects (60%) were Caucasian, 21 subjects (34%) were Hispanic, 2 subjects (3%) were African 
American, and 2 subjects (3%) were Caucasian and African American. 
 
PROCEDURE ADMINISTRATION 
Subjects received six total procedure administrations with the Erchonia® MLS (active or sham) 
to the right and left upper arms across a consecutive two-week period: three procedures per 
week, each procedure at two to three days apart, at the investigator’s test site. 
 
STUDY MEASURES 
Circumference measurements at three points on the upper arms, and body mass index (BMI) 
were recorded at baseline, study mid-point (week 1), study endpoint (week 2), and study follow- 
up two weeks later. Subject satisfaction with the procedure outcome was recorded at study 
endpoint. 
 
STATISTICAL ANALYSIS 
The study primary outcome measure was based on individual circumference measurements 
taken at 3 points along each of the subject’s upper arms combined to attain a single 
circumference measurement for each of the right arm and the left arm, separately. 
 
It was pre-determined that a subject would be considered a study success if he or she attained a 
1.25 cm or greater reduction in combined circumference measurement for each of the right and 
left upper arms, separately, from baseline to study endpoint (after completion of the two- week 
procedure phase). 
 
58% of subjects who received the study procedures with the actual Erchonia® MLS attained a 
decrease in combined circumference measurement of 1.25 cms or greater for each of the right 
and left upper arms, separately, compared with 3% of subjects who received the study 
procedures with a ‘fake’ (placebo) laser device. A Fischer’s Exact Test for two independent 
proportions found this difference of 55% to be statistically significant at p<0.000005. 
 

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CHANGE SCORES 
The mean change in total circumference for subjects who received the study procedures with 
the actual Erchonia® MLS was a decrease of 1.85 cms for the right upper arm, a decrease of 
1.84 cms for the left upper arm and decrease of 3.70 cms for both upper arms combined. The 
mean change in total circumference for subjects who received the study procedures with the 
‘fake’ (placebo) laser device was a decrease of 0.08 cms for the right upper arm, a decrease of 
0.23 cms for the left upper arm and decrease of 0.31 cms for both upper arms combined. 
 
Paired samples t-tests found the changes in upper arm circumference measurements for 
subjects in the test group to be statistically significant, as shown in Table 1 below. The changes 
in upper arm circumference measurements for subjects in the placebo group were not found to 
be statistically significant, as shown in Table 2 below. 
 
 
 
Table 3 and Chart 1 below show the mean change in total upper arm circumference 
measurements (right and left arms combined) across the four study measurement time points. 
 
Table 3: Mean total circumference 
 
 
 
 
 
 
 
 
 
 
Chart 1: Mean change in total upper arm measurements (cms) across evaluation points  
circumference measurements (cms) at each study evaluation point relative to baseline. 
 
Test 
Group 
Placebo 
Group 
Baseline 
191.48 
189.58 
Midpoint (week 1) 
189.47 
189.69 
Endpoint (week 2) 
187.78 
189.27 
Follow-up (week 4) 
188.04 
189.34 

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STUDY OUTCOME SATISFACTION RATINGS 
At completion of the study procedure administration phase, the subject was asked to rate how 
satisfied he or she was with any overall change in the appearance of the upper arms attained 
using the following five-point scale: Very Satisfied; Somewhat Satisfied; Neither Satisfied nor 
Dissatisfied; Not Very Satisfied; Not at All Satisfied. Sixty-five per cent (65%) of test group 
subjects reported being ‘Satisfied’ (Very or Somewhat Satisfied) with the outcome of the study 
procedures compared with 22% of placebo subjects. 
 
ADVERSE EVENTS 
No adverse event occurred for any subject throughout the duration of the clinical study. There 
was no change in skin markers in the treated body areas, and no notable deviation from 
baseline diet, exercise or concomitant medication use for any study subject. 
 
A double-blind, placebo-controlled randomized evaluation of the effect of the Erchonia® 
ML Scanner (MLS) on body contouring of the waist, hips and thighs clinical study 
protocol: Version 5, September 18, 2007. 
 
PURPOSE OF STUDY 
The purpose of this clinical study was to determine the effectiveness of the Erchonia® ML 
Scanner (MLS) manufactured by ERCHONIA CORPORATION (the Company) as a non- 
invasive alternate therapy to liposuction for the purpose of body contouring of the waist, hips and 
thighs. 
 
DEVICE DESCRIPTION 
The Erchonia® MLS laser device used in this study employed 635 nm red laser diodes. 
 
STUDY DESIGN 
This clinical study was a placebo-controlled, randomized, double-blind parallel group three- 
center design. 
 
STUDY SUBJECT POPULATION 
There were 67 enrolled subjects: 35 randomized to the active treatment group and 32 
randomized to the placebo group. Sixty-four (64) subjects were female, and 3 subjects were 
male. Sixty-six (66) subjects were Caucasian, and one was Caucasian and African American. 
 
PROCEDURE ADMINISTRATION 
Each subject received six total procedure administrations with the Erchonia® MLS (active or 
sham) across a consecutive two-week period: three procedures per week, each procedure at 
least two days but no more than three days apart, at the investigator’s test site. 
 
STATISTICAL ANALYSIS 
The primary efficacy outcome measure was defined as the change in total combined inches in 
circumference measurements (waist, hips and bilateral thighs) from study baseline (pre- 
procedure) to study endpoint (following completion of the two-week procedure administration 
phase with the Erchonia® MLS laser device). The individual subject success criteria was 
defined as at least a 3.0-inch reduction in combined circumference measurements for the waist, 
hips and bilateral thighs from baseline to endpoint. Overall study success criteria was defined as 
at least a 35% difference between treatment groups, comparing the proportion of individual 
successes in each group. 
 
 

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PRIMARY OUTCOME MEASURE ANALYSES 
Table 1 below shows the number and percentage of test and placebo group subjects who met 
the study individual subject success criteria 
 
Table 1: Individual Success Criteria met by treatment group 
Test subjects 
Placebo subjects 
n 
35 
32 
n meeting success criteria 
22 
2 
% meeting success criteria 
62.86% 
6.25% 
 
There is a difference of 56.61% between procedure groups, such that 56.61% more test 
group than placebo group subjects showed a total decrease in combined circumference 
measurements from pre-procedure to study end point of 3 inches or greater, exceeding the pre- 
established target of a 35% difference between treatment groups by almost 22%. A Fischer’s 
Exact Test for two independent proportions was conducted to compare the proportion of 
successes between treatment groups. The results are as follows: 
 
2 X 2 Table 
Success Met 
Success Not Met 
 
Test Group 
22 
13 
35 
Placebo Group 
2 
30 
32 
24 
43 
67 
 
• p(one-tailed) < 0.00001 
• p(two-tailed) < 0.00001 
 
The difference was found to be statistically significant at p<0.00001, meaning that the two 
treatment groups gave significantly different results, such that the greater treatment effect 
observed for subjects in the test group relative to subjects in the placebo group is statistically 
significant and can be attributed to the efficacy of the application of the Erchonia® MLS over a 
placebo device. 
 
CHANGE SCORES 
A t-test for independent samples was conducted to compare the two independent group 
means for the continuous variable of mean change in combined circumference (total number of 
inches) from study baseline to end point. The difference was found to be statistically 
significant at p<0.0001: µa-µb=-2.8378; t=-7.30; df=65; p(two-tailed)<0.0001, such that the 
mean decrease in number of total inches for test group subjects was significantly greater than 
for placebo group subjects. In confirmation, a One-Way ANOVA for 2 Independent Samples 
was conducted to compare the same two independent group means for means changed in 
combined inches lost. The results were significant at p<0.0001 (F=53.36). 
 
Circumference measurements were recorded at baseline, end of procedure administration week 
1, end of procedure administration week 2 (study end point) and 2 weeks post-procedure. Table 
3 below shows the mean and standard deviation total circumference measurements by 
treatment group at each of the four time points. 
 
 
 
 

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Table 3: Total circumference measurements across study duration by treatment group 
Test Group 
Placebo Group 
n 
Mean 
St. Dev. 
n 
Mean 
St. Dev. 
Baseline 
35 
120.31 
7.96 
32 
122.99 
10.54 
Week 1 
35 
118.25 
8.31 
32 
122.73 
10.49 
Week 2 
35 
116.79 
8.11 
32 
122.31 
10.82 
2 weeks post 
35 
117.09 
7.96 
32 
122.37 
10.43 
 
A double-blind, placebo-controlled, randomized evaluation of the effect of the Erchonia® 
Obesity Laser on the reduction of the circumference of the hips, waist and upper 
abdomen for individuals with Body Mass Index (BMI) of 30 to 40 kg/m²: Version 1.0, 
February 20, 2013 
BACKGROUND 
The purpose of this clinical study was to determine the effectiveness of the Erchonia® Obesity 
Laser in reducing circumference of the hips, waist and upper abdomen when applied to 
individuals with a Body Mass Index (BMI) between 30 kg/m² and 40 kg/m², by applying the laser 
to the treatment area 12 times across 4 consecutive weeks.   
 
STUDY DESIGN 
The study was a placebo-controlled, randomized, double-blind parallel group design conducted 
across two independent test sites.  
 
SUBJECTS 
Fifty-three (53) subjects completed the study, 28 of whom were randomized to the active 
procedure group and 25 who were randomized to the placebo group.  
 
Subjects were 18 to 65 year old males and females with Body Mass Index (BMI) between 30 
kg/m² and 40 kg/m² who were indicated for liposuction or use of liposuction techniques for 
the removal of localized deposits of adipose tissues that do not respond to diet and exercise. 
 
Subject age averaged 47.09 years. Most subjects were Caucasian and there were more female 
than male subjects, as shown in Table 1 below.  
 
Table 1: Baseline demographics 
Gender 
Female 
Male 
n=53 
number 
% 
number 
% 
 
45 
85% 
8 
15% 
Ethnicity 
Caucasian 
African American 
Hispanic 
Caucasian/Hispanic 
n=53 
number 
% 
number 
% 
number 
% 
number 
% 
 
41 
77% 
9 
17% 
2 
4% 
1 
2% 
 
STUDY MEASURES 
The study primary outcome measure of combined hips-waist-upper abdomen circumference 
was measured at baseline, mid-point (two weeks) of the procedure administration phase, at 
completion of the four-week procedure administration phase (study endpoint) and two weeks 
after completion of the procedure administration phase. Body Mass Index (BMI) was also 
measured at these same assessment points. Subject satisfaction with procedure outcome and 
subject and assessment investigator perceived subject group assignment were recorded at 
endpoint.  

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BASELINE MEASUREMENT 
Table 2 below contains the mean (average) baseline circumference measurements (inches) and 
body mass index (BMI) by procedure group.   
 
Table 2: Mean (Average) baseline measurements by procedure group  
Circumference Measurements (inches) 
Test Group (n=28) 
Placebo Group (n=25) 
Hips 
44.53 
43.11 
Waist 
39.60 
40.43 
Upper Abdomen 
39.22 
39.27 
Total Body Circumference  
123.35 
122.81 
Body Mass Index (BMI: kg/m²) 
34.58 
33.60 
 
A series of t-tests for independent samples found there was no statistically significant difference 
in any of the above baseline measurements between subject procedure groups (p>0.05).   
 
STUDY PROCEDURE 
Subjects received twelve thirty-minute procedure administrations with the Erchonia® Obesity 
Laser across the frontal and dorsal aspects of the hips-waist-upper abdomen treatment region 
across a consecutive four-week period: three procedures per week, each procedure two or 
three days apart. 
 
STUDY RESULTS 
The study primary outcome measure was defined as the change in total combined inches in 
circumference measurements (hips, waist and upper abdomen) from baseline (pre-procedure) 
to following completion of the four-week procedure administration phase (study endpoint). It was 
pre-determined that a subject would be considered a study success if he or she attained a 3.0 
inch or greater reduction in total combined circumference across this primary evaluation period. 
It was also pre-determined that the study would be considered an overall success if the 
proportion of individual subject successes in the test (active procedure) group was at least 40% 
greater than the proportion of individual subject successes in the placebo (sham procedure) 
group.  
 
71.43% of subjects who received the active study procedures with the Erchonia® Obesity Laser 
attained a decrease in combined circumference measurements of 3.0 inches or greater 
compared with 12% of subjects who received the ‘fake’ (placebo) laser procedures. A Fischer’s 
Exact Test for two independent proportions found this difference of 59.43% between subject 
procedure groups to be statistically significant at p<0.00005. 
 
The mean change in combined circumference measurement for subjects who received the 
active study procedures with the Erchonia® Obesity Laser was a decrease of 4.14 inches, while 
the mean change in combined circumference measurements for subjects who received the 
‘fake’ (placebo) laser procedures was a decrease of 0.71 inches. A t-test for two independent 
samples found the mean change in combined circumference measurements from baseline to 
study endpoint for test (active procedure) group subjects to be significantly greater than that for 
placebo (sham procedure) group subjects, at p<0.0001.  
 
Table 3 and Chart 1 below show the mean change in combined circumference measurements 
across the four study evaluation points for test and placebo group subjects.  
 
 

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Table 3: Mean total circumference                          Chart 1: Mean change in total circumference 
measurements (ins.) across evaluation points        measurements (ins.) at each study   
     
 
 
 
 
                      evaluation point relative to baseline                      
 
 
Test 
Group  
Placebo 
Group 
Baseline 
123.35 
122.81 
Midpoint (week 2) 
120.86 
122.09 
Endpoint (week 4) 
119.21 
122.10 
2 Weeks Follow-up 
118.73 
122.08 
 
 
For test subjects, total circumference measurements decreased progressively from baseline at 
each of the three subsequent evaluation points culminating in a mean decrease of 4.62 inches 
by 2 weeks post-procedure evaluation. For placebo subjects, the magnitude of the change was 
constant for all three subsequent evaluation points relative to baseline, indicating lack of any 
change in total circumference measurements beyond week 2 evaluation relative to baseline. 
Additionally, the magnitude of the changes relative to baseline for placebo group subjects were 
notably less that the respective changes for test group subjects relative to baseline. Considered 
together, these findings support progressive effectiveness of the Erchonia® Obesity Laser 
procedures over time compared with placebo. 
 
At completion of study procedure administration, the subject was asked to rate how satisfied he 
or she was with any overall perceived change in the appearance of the hips-waist-upper 
abdomen area using the following five-point scale: Very Satisfied; Somewhat Satisfied; Neither 
Satisfied nor Dissatisfied; Not Very Satisfied; Not at All Satisfied. 79% of test group subjects 
reported being ‘Satisfied’ (‘Very Satisfied’ or ‘Somewhat Satisfied’) with the study outcome 
compared with 16% of placebo subjects.   
 
ADVERSE EVENTS 
No adverse event occurred for any subject throughout duration of the clinical study. There was 
no change in skin markers in the treated body areas, and no notable deviation from baseline 
diet, exercise or concomitant medication use for any study subject. 
 
CONCLUSION 
The Erchonia® Obesity Laser is an effective tool for reducing circumference measurements of 
the hips-waist-upper abdomen in individuals with Body Mass Index (BMI) between 30 kg/m² and 
40 kg/m² over a 4-week period. 
 
 
 
 
 
 
 
 
 
 
 

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STUDY DESIGN 
This clinical study is a prospective open-label design with post-study independent blinded 
outcome analysis to evaluate the efficacy of the Erchonia® CFL Laser in providing noninvasive 
fat reduction in the submental area. As such, all enrolled subjects will receive active study 
treatments, and therefore, randomization to procedure group is not applicable. 
 
STUDY BLINDING 
As all subjects in this study will receive active procedure administrations with the Erchonia® 
CFL, neither subjects nor treating investigators will be blinded. 
 
However, study outcome assessments, including primary study success determination, will be 
blinded through use of three (3) Independent Blinded Evaluators who will assess the study 
primary efficacy outcome through evaluation of coded, deidentified photographic images of 
subjects’ submental regions’ before (pre-treatment) treatment and 12 weeks after treatment 
(Week 16 Endpoint) that are provided in randomized order post-study endpoint. The digital 
photographs will be presented to each Independent Blinded Evaluator in blinded coded 
randomized fashion, with. randomization of photograph presentation order additionally occurring 
across test sites. Each Independent Blinded Evaluator will perform and record the study primary 
efficacy outcome assessment independently of each other, without input, consultation, 
comparison of determinations, or any other form of interaction or communication with each other 
during the assessment process. The Independent Blinded Evaluators will not have otherwise 
been involved with any aspect of study design or execution. 
 
Randomization of order of subject post-hoc photo presentation will be attained using computer 
generation sequence methodology (www.randomization.com) ensuring that the randomization 
methodology and the generated allocation sequence is concealed from the Independent Blinded 
Evaluators. Each computer-generated randomization sequence is unique and will therefore not 
be able to be replicated. 
 
INDEPENDENT BLINDED EVALUATORS 
Independent Blinded Evaluators participating in this study will be licensed and qualified 
physicians such as MD’s, DO’s, Dermatologists, Plastic surgeons, Cosmetic surgeons, and 
Board-certified weight loss physicians who are trained and experienced in visualizing, treating, 
and observing for change in submental fat. 
 
SUBJECTS  
 
Subject Sample 
Subjects will be males and females 18 to 65 years of age who present with visible fat bulges in 
the submental area and who subsequently satisfy all qualification criteria. 
 
Sample Size 
There will be 35 qualified subjects enrolled in this study. 
 
Rationale for Sample Size 
In consideration of the primary efficacy outcome assessment, a clinically important outcome is 
pre-established as at least 2 of the 3 Independent Blinded Evaluators correctly identifying a 
subject’s Pre-Treatment and Post-Treatment (study Endpoint of Week 16 – 12 Weeks Post-
Treatment End) photographic images of the submental region, with study success defined as a 
Responder Rate of 80% or greater.  
 

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Consequently, the planned sample size to provide sufficient power for a statistical comparison of 
the proportion of treatment responders (P) versus a reasonable cutoff (P0) is based on a power 
calculation utilizing the (one proportion) binomial exact test based on the following assumptions.  
 
• H0: P ≤ P0 versus Ha: P > P0  
• Type I error rate: α = 0.025   
• Power = 90% 
• Population proportion under the null hypothesis: P0 = 0.80  
• Population proportion under the alternative hypothesis: P = 0.50  
• Total N = 30 study participants 
 
To account for a potential 15% subject attrition rate, a total of 35 subjects will be enrolled. 
 
Recruitment 
Subjects will be recruited from among: 
(i) The test site’s pool of existing and new clients 
(ii) Subjects who respond to the recruitment materials found in Appendix C. 
 
Compensation 
A subject will not be offered money or any other form of compensation to participate in the study; 
however, he or she will also not be charged for the cost of the study procedures with the 
Erchonia® CFL or for the cost of any other directly-related evaluations or measurements that 
occur as part of his or her participation in the study.   
 
 
STUDY PROCEDURE 
 
STUDY TEST BATTERY 
The following is a list of the study measurement tools to be used in this study. For each study 
phase, the precise tools from this list that will be employed will be specified.   
 
BODY MASS INDEX (BMI): BMI is calculated as the ration of the subject's weight in kilograms 
(or pounds) to the square of the subject’s height in meters (or feet). 
PHOTOGRAPHS: Subjects will be photographed in a seated position. High-resolution digital 
images will be taken from the frontal view and from each lateral view (right and left side) at each 
evaluation visit. Photographs will be acquired using a standardized photography set-up (Apple 
iPad 12 [12-megapixel], ring light tripod) to ensure consistency, and will be taken in a 
standardized manner in the same room under the same lighting conditions, with effort made for 
the images to be taken by the same individual, with the same system settings fixed at the same 
location, with all subjects situated at the same distance from the lens for each photograph. At 
each post-baseline visit, the photographer will refer to the baseline photographs to ensure 
consistency in subject positioning and exposure. These same protocols will be employed across 
all study test sites. 
 
Detailed instructions and the protocol for capturing the photographs are contained in Appendix 
B: Photograph Methodology Instruction Sheet. 
 
SKINFOLD MEASUREMENT: The caliper measurement process involves pinching the tissue 
within the treatment area to obtain the measurement, thereby folding the tissue, and doubling the 
fat layer thickness. Measurements are taken with subjects standing in a neutral position, with the 

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head slightly lifted yet allowing the skin of the neck to remain loose such that a vertical fold is 
created above the hyoid bone. 
The total measured value (mm) will be halved to reflect a single fat layer change and will not 
take into account the fold of tissue during the measurement process.  
 
DEMOGRAPHICS: Age, gender, ethnicity, and Body Mass Index (BMI) 
 
SUBJECT SATISFACTION WITH STUDY OUTCOME: The subject is asked to rate how satisfied 
he or she is with any change in the appearance of the fat pad under the chin following completion 
of the laser administration procedure with the Erchonia® CFL by using the 5-point Likert scale 
below to respond to the following question:  
 
“Overall, how satisfied or dissatisfied are you with any change in the appearance of the fat pad 
under your chin following the study procedures with the study laser device?”  
 
• Very Satisfied 
• Somewhat Satisfied 
• Neither Satisfied nor Dissatisfied 
• Not Very Satisfied 
• Not at All Satisfied   
 
STUDY PROCEDURES 
 
PRE-TREATMENT  ACTIVITIES 
The pre-treatment activities will be conducted at the test site prior to administration of the initial 
study treatment with the Erchonia® CFL. 
 
SIGNING OF INFORMED CONSENT FORM 
The investigator will commence by presenting and reviewing in detail the items in the informed 
consent form with the individual and answer any questions. To proceed, the individual must 
willingly sign the informed consent form. 
 
ASSIGNMENT OF SUBJECT ID 
The subject will be assigned a unique subject identification number based upon his or her order 
of entry into the study. 
 
Additional information about the informed consent and subject ID number assignment is contained 
in a later section of the protocol titled, “SAFETY AND CONFIDENTIALITY ISSUES.” 
 
STUDY QUALIFICATION EVALUATION: INCLUSION/EXCLUSION CRITERIA  
 
INCLUSION CRITERIA 
To be eligible for participation in this study, a subject must satisfy each of the following. 
 
 Male or female 18 to 65 years of age, inclusive.  
 Submental and submandibular skin fold thickness > 1cm (measured by caliper). 
 Subject agrees to maintain his/her weight (i.e., within 5%) by not making any major changes 
in diet or exercise routine during the course of the study.  

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 Subject agrees to abstain from partaking in any treatment to promote body contouring and/or 
weight loss during the course of study participation. Such treatments include, but are not 
limited to:  
• over-the-counter and/or prescription medications; dietary/herbal supplements and 
appetite suppressants. 
• weight loss programs/diet plans. 
• surgical procedures for sculpting of the chin fat pad/weight loss, e.g. submental 
lipectomy, lap bands 
 Subject has signed a written informed consent form. 
 
EXCLUSION CRITERIA 
A subject who satisfies any of the following criteria will be excluded from study participation: 
 
 Evidence of any cause of enlargement in the submental area other than localized 
subcutaneous fat, such as swollen lymph nodes or ptotic submandibular glands. 
 Treatment with dermal fillers, radiofrequency or laser procedures, or chemical peels in the 
neck or chin area (below the mandible) within the past 6 months. 
 Botulinum toxin or other aesthetic drug injections within the neck or chin area (below the 
mandible) within the past 6 months. 
 History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.) or 
implant in or adjacent to the area of intended treatment. 
 Any dermatological conditions, such as scars in the location of the treatment area that may 
interfere with the treatment or evaluation. 
 Active implanted device such as a pacemaker, defibrillator, or drug delivery system. 
 Pregnant or intending to become pregnant in the next 6 months. 
 Currently enrolled in a clinical study of an unapproved investigational drug or device. 
 
PRE-TREATMENT EVALUATIONS 
The following pre-treatment measures will be recorded prior to commencement of the treatment 
administration phase (prior to treatment administration #1). 
 
BASELINE VARIABLES 
• Subject Demographics  
• Body Mass Index (BMI) Calculation 
• Concomitant Medication and Therapy Use 
 
PRE-TREATMENT OUTCOME ASSESSMENTS  
• Photographs 
• Skinfold measurements (mm).  
 
The Pre-Treatment photographs and skinfold caliper measurement will serve as the Baseline 
data set for relative assessment of post-treatment change. 
 
 
 

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TREATMENT ADMINISTRATION PHASE 
 
TREATMENT ADMINISTRATION PROTOCOL   
 The treatment administration phase of the study may commence on the same day as the 
pre-treatment measurements are recorded.    
 The treatment administration phase will extend over four consecutive weeks.  
 Each subject will receive eight (8) treatment administrations with the Erchonia® CFL across 
the consecutive four-week treatment administration phase; two treatments per week; each 
one at least two days apart. 
 Each treatment will take place at the investigator’s test site. 
 The treatment administration protocol for each session is as follows: 
 
1. The subject enters the treatment administration room and lays comfortably on a 
treatment table. 
2. The subject is correctly fitted with the safety glasses. 
3. Utilizing the flexible laser stand, the investigator positions the Erchonia® CFL at a 
distance of about 3-4 inches from the surface of the skin, the device itself never touches 
the skin surface.  
4. The device is aligned so that the emitted laser light beams that cross forming an “X” is 
centered on the fat pad under the chin.  
5. The Erchonia® CFL treatment will run for fifteen (15) continuous minutes and will stop 
once the treatment time is at 0:00. Once the “Time Remaining” display reaches 0:00 the 
treatment is complete, the laser lights and the laser indicator light will turn off. 
6. After the Erchonia® CFL is turned off, the subject removes the safety glasses and 
leaves the treatment administration room. 
 
TREATMENT ADMINISTRATION RECORD 
Following the completion of each treatment with the CFL laser, the investigator will record the 
following: 
 Number of treatment administrations  
 Date 
 Investigator signature 
 Adverse event (if applicable). 
 
POST-TREATMENT ACTIVITIES 
 
WEEK 4 EVALUATION: TREATMENT ENDPOINT: AT THE TIME OF TREATMENT 
PROTOCOL END 
Following the final treatment at completion of the 4 weeks of study treatment administrations with 
the Erchonia® CFL, the following will be recorded on the provided Case Report Forms.  
 Photographs 
 Skinfold caliper measurements (mm) 
 Body Mass Index (BMI) Calculation 
 Subject Satisfaction with Study Outcome 
 
WEEK 16 EVALUATION: STUDY EFFICACY ENDPOINT: 12 WEEK POST TREATMENT  
ADMINISTRATION END 
Twelve (12) weeks following the completion of the 4-week treatment administration protocol, the 
following will be recorded on the provided Case Report Forms. These recordings will form the 
study endpoint data set from which change from baseline will be evaluated with respect to 

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assessing study outcome. 
 Photographs 
 Skinfold caliper measurements (mm) 
 Body Mass Index (BMI) Calculation 
 Subject Satisfaction with Study Outcome 
 
ADVERSE EVENTS  
At each evaluation point throughout the clinical study, and at any other time throughout the 
duration of the clinical trial that is necessary, any and all potential adverse events reported by a 
subject or observed by an investigator will be recorded on the case report form, and subsequently 
evaluated by a suitably qualified independent reviewer for determination of relationship to the 
study treatment and whether or not any corrective action needs to be taken. All potential adverse 
events recorded will be appropriately reported to the governing IRB, as applicable. 
 
It is unlikely and not expected that any adverse events will result from implementation of this 
clinical study protocol. Prior clinical trials using low level laser light have not typically yielded any 
adverse events or reactions. However, potential adverse events that may feasibly occur from 
application of the Erchonia® CFL include, but are not necessarily limited to: skin irritation, 
discoloring, rash, indentations and infection. 
 
PRIVACY AND CONFIDENTIALITY 
Records for each subject in this clinical study will be maintained in separate files in a locked filing 
cabinet at the respective test site. The investigator at the test site will be responsible for ensuring 
that all records for a subject pertaining to his or her participation in the clinical study are stored in 
that subject’s file at all times other than when information is being recorded on them.   
 
Copies of all of the subject case report forms will be made and supplied to Erchonia Corporation 
who will maintain these copies in a separate clinical study file that is kept in a locked filing cabinet 
at their premise. The original records will be maintained at the respective test sites.  
 
Subjects’ identities will be kept confidential by assigning each subject a subject ID upon 
acceptance into the study. The subject ID will comprise the investigator’s first and last name 
initials followed by a three-digit number determined according to the subject’s order of entry into 
the study. The first test site will be assigned a range of numbers from 001 to 100.  The second 
test site will be assigned a range of numbers from 101 to 200. For example, the eighth subject to 
be enrolled at the first test site under PI John Black would have a subject ID of JB008. Neither 
the study Sponsor, Monitor,  biostatistician, Independent Blinded Evaluators, nor any other 
pertinent party will receive any additional identifying information about a subject and will therefore 
have no way of linking a Subject ID to a particular subject and his or her study results.   
 
 
 
 
 
 
 
 
 
 
 
 

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STATISTICAL ANALYSIS PLAN 
 
STUDY POPULATIONS 
The following two study populations will be evaluated: 
 
1. Intent-to-Treat (ITT) Population  
 
Primary analysis of efficacy will be according to the intent to treat (mITT) analysis, including all 
consented and enrolled subjects.  
 
 
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 
inclusive of all assessment visits and activities and the full 4-week, 8-treatment administration 
protocol. 
 
3. Handling of Missing Data 
Missing data values will be imputed using regression analysis imputation methodology under the 
assumption of the data missing at random (MAR), provided that the assumption of the data being 
MAR can be supported as has been found through prior Erchonia studies and demonstrated 
through the following means, the first two of which are already established by the study design: 
1. As there is no placebo group in this clinical study design, subjects are aware that they are 
receiving active study treatments, and therefore, subject lost to follow up cannot be attributed 
to potential study unblinding. 
2. The primary outcome assessment is a binary response responder rate format determined by 
Independent Blinded Evaluators that is therefore independent of individual subject variables. 
3. Comparison of demographics for the group of subjects with missing data to the entire subject 
ITT  group will be performed to demonstrate comparability. 
4. Comparison of the primary outcome assessment for the group of subjects with missing data 
to the entire subject ITT  group will be performed to demonstrate comparability. 
 
Given that the assumption of the data being MAR is supported, the missing data will be imputed 
using the regression imputation methodology with known variables approach wherein the 
regression equation is employed to calculate the marginal or conditional average for each 
individual subject’s missing value based on the known Baseline value of the missing variable 
value being imputed for that subject if available or if not available, on the known Baseline value 
for other subject(s) with comparable demographic profiles. 
 
DEMOGRAPHICS 
The following subject demographics collected at the Pre-Treatment assessment visit will be 
analyzed descriptively as means, standard deviations, medians, and range (minimum, 
maximum) for continuous data and as number (N) and percentages(%) of the total sample for 
categorical data and presented in table format, as applicable for the ITT subject population.  
• Gender 
• Age 

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• Ethnicity 
• Body Mass Index (BMI): weight (kg), Height (inches / meters). 
 
BASELINE SKINFOLD MEASUREMENTS  
Baseline skinfold measurements (mm) and submental skinfold thickness (mm) measurements will 
be presented descriptively in table format as means, standard deviations, medians, and range 
(minimum, maximum) for the ITT subject population. 
 
BASELINE CONCOMITANT MEDICATION USE 
Recorded baseline concomitant medication use will be presented in table format as number (N) 
and percentage (%) of totals and reported as individual medications and further groups by 
indication for use for the ITT subject population.  
 
PRIMARY EFFICACY OUTCOME ANALYSIS 
 
The primary goal of this study is to determine if the treatment effect of the Erchonia© CFL can 
affect the appearance of visible fat bulges in the submental area. 
 
PRIMARY STUDY SUCCESS EVALUATION CRITERIA  
 
The primary efficacy outcome for this clinical study is established as the proportion of accurately 
identified subject pre- and post-treatment photographs by at least two of the three Blinded 
Independent Evaluators. 
 
In consideration of this primary efficacy outcome assessment, a clinically important outcome is 
defined as at least 2 of the 3 Independent Blinded Evaluators (i.e., 2 out of 3, or 3 out of 3) 
correctly identifying the order of a subject’s Pre-Treatment (Baseline) and Week 16 (Endpoint) 12 
Weeks Post-Final Treatment photograph for 80% or more of subjects.  
 
This clinically important minimum upper limit criteria of 80% was selected to be identical to the 
respective primary efficacy endpoint assessment parameters from the clinical studies for the 
ZELTIQ CoolSculpting System (K151179), and SculpSure (K171992) whose outcomes 
successfully supported FDA clearances for the same indication as intended to be supported by 
the outcome of the current clinical study protocol.  
 
HYPOTHESES 
 
The null and alternative hypotheses for the Primary Efficacy Endpoint are the following: 
 
Null Hypotheses: The overall responder rate will be less than 80%. 
 
Ho: µA < 80%  
 
Alternative Hypothesis: The overall responder rate will be 80% or greater. 
 
Ho: µA ≥ 80%  
 
PRIMARY EFFICACY OUTCOME ANALYSIS POPULATION 
Determination of primary efficacy outcome success will be according to analysis of the outcome 

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for the subject ITT population as the primary analysis population. Primary efficacy outcome 
success will also be evaluated for the study Per Protocol population as a secondary analysis to 
provide support for and confirm the outcome of the primary analysis performed on the ITT 
subject population.  
 
PRIMARY EFFICACY OUTCOME STATISTICAL EVALUATION 
Primary study efficacy will be evaluated at Week 16, 12 Weeks Post-Final Treatment 
administration relative to Baseline (Pre-Treatment).  
 
Primary efficacy outcome success will be evaluated via Responder Rate Analysis, wherein:  
 
(i) 
An individual subject is defined as a Study Responder if at least 2 of the 3 Independent 
Blinded Evaluators correctly identify the subject’s post-treatment photograph, and 
(ii) Overall study success is defined as a minimum responder rate of 80%.   
 
To determine primary efficacy outcome success, the following process will be followed: 
 
1. The percentage of individual Study Responders will be calculated to determine the 
responder rate. 
2. If the calculated responder rate is 80% or greater (≥ 80%), it will be concluded that primary 
efficacy success has been demonstrated. 
3. If the calculated responder rate is less than 80% (< 80%), it will be concluded that primary 
efficacy success has not been demonstrated. 
 
 
 
SECONDARY EVALUATIONS The secondary efficacy outcomes of submental skinfold and 
submental skinfold thickness, and subject satisfaction with treatment outcome will be assessed 
for each of the ITT and Per Protocol analysis populations, as applicable. As these secondary 
outcomes are provided as supportive evidence for the primary efficacy outcome only and the 
Sponsor does not intend to seek clearance for any claims  based on findings of these 
secondary efficacy outcomes, the findings will be presented descriptively only as means, 
standard deviations, medians, and ranges for the continuous data and as number (N) and 
percentage (%) of the total for categorical data and will be presented in table and chart format, as 
applicable. Statistical analysis of change will not be performed.  
 
• Submental skinfold and submental skinfold thickness measurements (mm) data will be 
recorded at each of the Pre-Treatment (Baseline), Week 4 (Treatment End), and Week 16 (12 
Weeks Post-Treatment End) visits.  
• 
Subject satisfaction with study outcome ratings will be recorded at each of the Week 4 
(Treatment End) and Week 16 (12 Weeks Post-Treatment End) visits. 
 
‘Positive’ subject satisfaction with treatment outcome response is predefined as the sum of 
‘Very Satisfied’ and ‘Somewhat Satisfied’ responses. 
 
• Additionally, comparison of the mean, standard deviation, median, and range of Body Mass 
Index (BMI) recording at each of Pre-Treatment (Baseline), Week 4 (Treatment End), and 
Week 16 (12 Weeks Post-Treatment End) visits will be compared descriptively to confirm that 
changes in body BMI did not contribute to the study outcome.  
 
 
 

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SAFETY ANALYSES  
Safety analyses will be based on all subjects who signed informed consent and were enrolled in 
the study.  
 
Safety will be assessed by evaluating observed and/or reported adverse events.  
 
INFORMED CONSENT 
 
• 
Informed consent will be an agreement between the individual investigator and each 
subject, having the capacity to understand and make an informed decision. Consent will be 
obtained prior to each potential subject’s participation in this study. 
• 
Each subject participating in this study will be made aware of the fact that his or her 
participation involves research and the intent of the research, the expected duration of 
participation and a description of the procedures that will be followed.   
• 
Each subject will be made aware of the reasonably expected benefits he or she might 
receive, as well as any risks or potential discomfort that are involved.   
• 
Each subject will also be made aware of alternative treatments available to him or her.   
• 
Each subject will be made aware that his or her records will remain confidential, but that the 
FDA and the IRB has the right to inspect his or her records.   
• 
Each subject will be told that his or her participation in the study is voluntary, without force 
or influence from the investigator or sponsor. 
• 
Each subject will be given the name and method of contacting the appropriate person(s) to 
answer questions about the research and in the event of a research-related injury. 
 
The Subject Informed Consent Form can be found in Appendix D.  
 
CASE REPORT FORMS 
The case report forms that will be used to collect the data from each subject in this study can be 
found in Appendix E. 
 
 
 
 
 
 
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