Human Factors Validation Testing for Over-the-Counter Use of the Erchonia® LunulaLaser™ OTC
Phase: NA
Conditions: Onychomycosis
Sponsor: Erchonia Corporation

 
 
 
 
 
 
 
ERCHONIA CORPORATION  
 
 
LUNULALASER™ OTC 
 
 
 
Human Factors Validation Testing for  
Over-the-Counter Use of the  
Erchonia® LunulaLaser™ OTC 
 
 
 
Version 1.0 
May 04, 2021 

Erchonia LunulaLaser OTC Human Factors Validation Testing Protocol  
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TABLE OF CONTENTS 
 
1.  STUDY INFORMATION  ......................................................................................... 1 
       1.1.   SPONSOR ...................................................................................................... 1 
1.2.   STUDY OBSERVER ....................................................................................... 1 
1.3.   INSTITUTIONAL REVIEW BOARD................................................................. 1 
2. STUDY PURPOSE AND GOALS ............................................................................ 2 
2.1.   STUDY GOAL  ................................................................................................ 2 
2.2.   PURPOSE OF STUDY  .................................................................................. 2 
3. STUDY DEVICE: ERCHONIA CORPORATION LUNULALASER™ OTC. ............... 3 
4. STUDY DESIGN...................................................................................................... 4 
4.1.   STUDY DESIGN ELEMENTS ......................................................................... 4  
5. CRITICAL TASKS ANALYSIS ................................................................................. 5 
5.1.   CRITICAL TASK  ............................................................................................ 5 
5.2.   USER TASK  .................................................................................................. 5 
5.3.   USE ERROR  ................................................................................................. 5 
5.4.   HAZARDS  ...................................................................................................... 5 
5.4.1.   NON-USE RELATED HAZARD ........................................................... 5 
5.4.2.   USE RELATED HAZARD .................................................................... 6 
5.5.   ANALYTICAL APPROACHES ........................................................................ 6 
5.5.1.   TASK ANALYSIS TECHNIQUE ........................................................... 7 
5.5.2.   FAILURE MODES EFFECTS ANALYSIS (FMEA) ............................... 7 
5.6.   OUTCOME OF THE CRITICAL TASKS ANALYSIS ........................................ 8 
6. STUDY PARTICIPANT AND ENVIRONMENTAL DESIGN ..................................... 9 
6.1.   SUBJECTS (USERS AND CLIENTS) ............................................................. 9 
6.1.1.   USER SAMPLE ................................................................................... 9 
6.1.1.2.   USER SAMPLE SIZE ..................................................................... 11 
6.1.1.3.   USER SAMPLE RECRUITMENT ................................................... 12 
6.1.1.4.   SUBJECT USER COMPENSATION .............................................. 12 
6.1.2.   CLIENT SAMPLE .............................................................................. 12 
6.1.2.1.   CLIENT SAMPLE RECRUITMENT ................................................ 12 
6.1.2.2.   CLIENT USER COMPENSATION .................................................. 12 
6.2.   DEVICE USE ENVIRONMENTS ................................................................... 12 
6.3.   DEVICE USER INTERFACE......................................................................... 15 
6.4.   STUDY OBSERVER ..................................................................................... 19 
7. STUDY PROCEDURE........................................................................................... 20 
7.1.   STUDY MATERIALS .................................................................................... 20  
7.2.   STUDY PROCEDURE PROTOCOL ............................................................. 21 
7.2.1.   SIGNING OF INFORMED CONSENT ............................................... 21 
7.2.2.   ELIGIBILITY EVALUATION ............................................................... 21 
7.2.3.   PROVISION OF STUDY DEVICE ..................................................... 22 
7.2.4.   USER USE OF THE DEVICE ............................................................ 22 
7.2.5.   POST-TEST DEBRIEFING INTERVIEW ........................................... 23 
7.2.6.   KNOWLEDGE TASKS EVALUATION ............................................... 23 
8. REGULATORY AND ETHICAL CONSIDERATIONS ............................................. 23 
8.1.   DATA MANAGEMENT .................................................................................. 23  
8.1.1.   DATA ADMINISTRATION ................................................................. 23 
8.1.2.   COMPLIANCE STATEMENT ............................................................ 24 
8.2.   INFORMED CONSENT ................................................................................ 24  
8.2.1.   INFORMED CONSENT ..................................................................... 24 
8.2.2.   CONFIDENTIALITY .......................................................................... 24 

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8.3.   RISK ASSSESSMENT .................................................................................. 24  
8.3.1.   POTENTIAL RISKS OF PARTICIPATION ......................................... 24 
8.3.2.   POTENTIAL BENEFITS OF PARTICIPATION .................................. 24 
8.3.3.   RISK-BENEFIT ASSESSMENT ........................................................ 24 
9. SAFETY MANAGEMENT ...................................................................................... 25 
9.1.   USER DIFFICULTIES AND ERRORS .......................................................... 25  
9.2.   ADVERSE EVENTS REPORTING ............................................................... 25  
10. PUBLICATION..................................................................................................... 25 
11. ANALYSIS OF HUMAN FACTORS VALIDATION TESTING RESULTS .............. 25 
11.1.   PRIMARY ANALYSIS ................................................................................. 25 
11.2.   QUALITATIVE ANALYSIS .......................................................................... 26 
11.2.1.   ROOT CAUSE ANALYSIS .............................................................. 26 
11.2.2.   IMPLEMENTATION OF USER INTERFACE AND LABELING 
MODIFICATIONS .......................................................................................... 26 
11.2.3.  RETESTING ..................................................................................... 26 
11.2.4.  RESIDUAL RISK EVALUATION ....................................................... 26 
 
APPENDICES 
 
APPENDIX A: OUTCOME OF THE CRITICAL TASKS ANALYSIS 
APPENDIX B: ERCHONIA CORPORATION LUNULALASER OTC INSTALLATION AND 
PROPER USE REFERENCE GUIDE 
APPENDIX C: ERCHONIA CORPORATION LUNULALASER OTC BOX LABEL 
APPENDIX D: STUDY ELIGIBILITY EVALUATION: USERS CASE REPORT FORMS 
APPENDIX E: DEVICE USE STUDY OBSERVER OBSERVATION RECORD FORM 
APPENDIX F: POST-TEST DEBRIEFING INTERVIEW OBSERVERRECORD FORM 
APPENDIX G: KNOWLEDGE TASK USER QUESTIONNAIRE STUDY OBSERVER RECORD 
FORM 
APPENDIX H: LUNULALASER OTC HUMAN FACTORS VALIDATION STUDY USER 
INFORMATION AND CONSENT FORM 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1. 
STUDY INFORMATION 
 
1.1. SPONSOR 
Erchonia® Corporation 
650 Atlantis Rd.  
Melbourne, FL 32904 
 
Contact: Mr. Steven Shanks, President 
Telephone: 321-473-1251 
E-mail: sshanks@erchonia.com 
  
1.2. STUDY OBSERVER 
 
Travis Sammons 
Erchonia® Corporation 
650 Atlantis Rd.  
Melbourne, FL 32904 
 
Telephone: 321-473-1251 
E-mail: tsammons@erchonia.com 
 
1.3. INSTITUTIONAL REVIEW BOARD 
WCG IRB 
1019 39th Ave., SE 
Suite 120 
Puyallup, WA 98374 
Telephone: 855-818-2289 
E-mail: Clientservice@wcgirb.com 

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2. 
STUDY PURPOSE AND GOALS 
 
STUDY GOAL 
 
It is intended that the results of this Human Factors Validation Testing be used to support an 
over-the-counter (OTC) use indication for the LunulaLaser™ OTC for the temporary increase of 
clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. 
mentagrophytes, and/or yeasts Candida albicans, etc.). The indication for use is identical to the 
predicate device, the LunulaLaser™ cleared under K153164, with the only difference being the 
designation of Over-the-Counter (OTC) use.  The LunulaLaser™ OTC delivers a nonthermal 
and non-invasive procedure designed to restore growth of clear, healthy nails in clients with 
onychomycosis without harmful side effects of oral medication, or the pain and recovery time 
associated with other laser treatments. Therefore, it is intended that the results of this Human 
Factors Validation Testing will demonstrate that the LunulaLaser™ OTC can be used by the 
intended users without serious errors or problems for the intended use and under the expected 
use conditions.  
 
2.1. PURPOSE OF STUDY 
 
The purpose of the LunulaLaser™ OTC Human Factors Validation Testing is to: 
 
(i) 
evaluate the intended user’s ability to correctly, safely and effectively set-up, activate and 
operate the LunulaLaser™ OTC to administer the treatment to the client;   
(ii) evaluate the intended user’s ability to understand and apply as applicable the information 
contained in the LunulaLaser™ OTC Use Device Installation and Proper Use Reference 
Guide, and device packaging and labeling materials; and  
(iii) identify any and all use difficulties, problems and errors, including those pertaining to critical 
tasks and close calls demonstrated by intended users during device operation, and to 
subsequently mitigate each identified instance of use error through device and/or materials 
modification, and to subsequently evaluate the effectiveness of each modification, as 
applicable. 
 
 
 
 
 

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3. 
STUDY DEVICE: LUNULALASER™ OTC; ERCHONIA® CORPORATION  
 
The LunulaLaser™ OTC (Figure 1) is intended to be indicated for the 
temporary increase of clear nail in patients with onychomycosis (e.g., 
dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or 
yeasts Candida albicans, etc.) 
 
The LunulaLaser™ OTC is a nonthermal and non-invasive procedure 
designed to restore growth of clear, healthy nails in clients with 
onychomycosis without harmful side effects of oral medication, or 
the pain and recovery time associated with other laser treatments. 
 
The LunulaLaser™ OTC works by using a patented and clinically proven low-level laser 
technology. The Lunula laser combines two different wavelength lasers; one visible violet light 
(about 405 nanometer wavelength) for direct fungicidal activity and one visible red light (about 
635 nanometer wavelength) to stimulate a natural immune response. The two lasers work 
together to increase clear nail in individuals with toenail onychomycosis.   
 
The LunulaLaser™ OTC device and the intended use to be evaluated in this Human Factors 
Validation Study is identical to that which was cleared by FDA on June 3, 2016 for prescription 
use, as follows: 
 
510(k) # K153164 
Product Code: PDZ 
Class II 
Device Name: LunulaLaser 
Indications for Use: The LunulaLaser™ device is indicated for use for the temporary increase of 
clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. 
mentagrophytes, and/or yeasts Candida albicans, etc.) 
 
Additional device details are contained in the Installation and Proper Use Reference Guide 
contained in Appendix B. 
 
 
Figure 1: LunulaLaser™ OTC 

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4. STUDY DESIGN 
 
This study is an uncontrolled simulated-use human factors validation testing design to assess the 
intended user’s ability to correctly, safely, and effectively set-up, activate and operate the 
LunulaLaser™ OTC, to administer a treatment to a client, and to understand the information 
contained in the Erchonia LunulaLaser™ OTC Installation and Proper Use Reference Guide and 
box labeling.  
 
The study design is comprehensive in scope and conducted in a manner such that the results will 
be able to be generalized to the actual intended user and under intended conditions of actual use 
and be adequately sensitive to capture use errors arising from either the user interface design 
and/or the instructional and informative materials. Study data will be collected in a manner that 
will facilitate analysis of the root causes of use errors or problems during the testing. 
 
4.1. STUDY DESIGN ELEMENTS 
The key elements of the study design that support its ability to generalize study results to the 
intended user under intended use conditions are the following: 
  
(i) 
Users (test participants) will represent the intended (actual) users of the LunulaLaser™ OTC; 
that is, users will be employees at nail salons, beauty salons and spas, fitness and wellness 
centers, and the like; 
(ii) All critical tasks will be performed, observed and evaluated during the testing; 
(iii) The device user interface and all associated instructional/informational materials will 
represent the final intended post-clearance (actual use) design; and 
(iv) The simulated-use test conditions will be sufficiently realistic to represent the actual intended 
conditions of use. Under actual intended conditions of use, the user will receive the Erchonia 
LunulaLaser™ OTC device in its full packaging via delivery to the facility at which they are 
employed and will need to rely on the information/instructional information contained in the 
Installation and Proper Use Reference Guide and the device and packaging labeling to 
configure and operate the device for use.  
 
 
 

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(v) In this study, the user will simply be presented with the device in its intended packaging as if 
receiving it at their place of employment. No additional information, instruction or training will 
be provided by the Study Observer, or any other individual associated with the study. The 
user will be left to work out how to operate the Erchonia LunulaLaser™ OTC as 
independently and naturally as possible without interference or influence from the Study 
Observer. While the user will have received the instructional information in the packaging as 
in intended use, he or she will not be instructed to use any of the information. It will be up to 
the user as to if or how he or she chooses to use that information to set up operation of the 
device as would occur under actual conditions of intended use. 
 
5. 
CRITICAL TASKS ANALYSIS  
5.1. CRITICAL TASK: For the purpose of the critical tasks analysis for this study, a critical task 
is defined as a user task which, if performed incorrectly (use error) or not performed at all, 
would or could cause serious harm to the patient or user, where harm is defined to include 
compromised medical care (use-related hazard). Critical task analysis is part of the device 
risk analysis. 
 
5.2. USER TASK: A user task is defined as an action or set of actions performed by a user to 
achieve a specific goal i.e., safe, and effective use of the device for the intended purpose. 
 
5.3. USE ERROR: Use error is defined as a user action or lack of action that is different from 
that expected by the manufacturer and caused a result that was different from the result 
expected by the user; was not caused solely by device failure; and did or could result in 
harm.  
 
5.4. HAZARDS 
5.4.1. Non-Use Related Hazards: A non-use related hazard is a potential source of harm 
that is generally associated with instances of device or component failure that are not 
dependent on how the user interacts with the device. 
 
Non-use related hazards traditionally considered in risk analysis include:  
• Physical hazards (e.g., sharp corners or edges),  
• Mechanical hazards (e.g., kinetic or potential energy from a moving object),  
• Thermal hazards (e.g., high-temperature components),  

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• Electrical hazards (e.g., electrical current, electromagnetic interference (EMI)),  
• Chemical hazards (e.g., toxic chemicals),  
• Radiation hazards (e.g., ionizing and non-ionizing), and  
• Biological hazards (e.g., allergens, bio-incompatible agents and infectious agents).  
 
5.4.2. Use-Related Hazards: A use-related hazard is a potential source of harm derived 
from incorrect performance or lack of performance of a critical task by the device user 
interactions with the device. These hazards might result from aspects of the user interface 
design that cause the user to fail to adequately or correctly perceive, read, interpret, 
understand, or act on information from the device. 
 
Use-related hazards are related to one or more of the following situations:  
 
• Device use requires physical, perceptual, or cognitive abilities that exceed the abilities of 
the user; 
• Device use is inconsistent with the user’s expectations or intuition about device operation;  
• The use environment affects operation of the device and this effect is not recognized or 
understood by the user;  
• The particular use environment impairs the user’s physical, perceptual, or cognitive 
capabilities when using the device;  
• Devices are used in ways that the manufacturer could have anticipated but did not 
consider; or  
• Devices are used in ways that were anticipated but inappropriate (e.g., inappropriate user 
habits) and for which risk elimination or reduction could have been applied but was not.  
 
Both non-use related and use-related hazards associated with the Erchonia LunulaLaser™ OTC 
have been included in the risk analysis and management process.  
 
5.5 ANALYTICAL APPROACHES: Analytical approaches for identifying non-use related and 
use-related hazards (critical task analysis) include analysis of the expected needs of users of the 
new device, analysis of available information about the use of similar devices, and employment 
of one or more analytical methods.  
 

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5.5.1. Task Analysis Technique: Critical tasks analysis was conducted using the task 
analysis technique, defined as the process of studying how users of the device would likely 
perform each task and the potential use errors that may occur if any of the identified tasks are 
performed incorrectly or not performed at all. User interactions with the design interface will 
be examined with respect to perceptual inputs, cognitive processing and physical actions that 
comprise the successful execution of each individual task. Potential user errors that may arise 
from each of these task components will be analyzed to identify the potential consequences 
of the errors and the potential resulting harm from the errors. This comprehensive 
identification and categorization of user tasks led to the identification and development of the 
list of critical tasks that users should perform correctly for use of the Erchonia LunulaLaser™ 
OTC to be safe and effective.  
 
For this identified list of critical tasks, each individual critical task was categorized based on 
the severity of the potential harm that could result from use error(s), as identified in the risk 
analysis, with the goal of identifying the task(s) that, if performed incorrectly or not performed 
at all, would or could cause serious harm.  
 
5.5.2. Failure Modes Effects Analysis (FMEA): The risk analysis approach employed a 
team-based failure modes effects analysis (FMEA) to identify potential use errors and the 
potential harm that could result from each potential use error related to the user-device 
interaction as comprehensively as possible.    
 
All risks associated with the warnings, cautions and contraindications in the labeling are included 
in the risk assessment.  
 
The final list of critical tasks was used to structure the human factors validation test to ensure it 
focuses on the tasks that relate to device use safety and effectiveness. While every effort has 
been made to identify and consider all critical tasks, associated use errors and potential resultant 
harm to the user and/or patient from use error, it is possible that some potential use errors might 
not be recognized until the human factors validation testing is conducted. The test protocol 
therefore includes mechanisms to detect previously unanticipated use errors. 
 
As part of the risk analysis process, identification of known use-related problems, if any, that 
have occurred with the use of similar devices with regards to use, the user interface or user 

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interactions, will be identified, considered, and evaluated as applicable to the Erchonia 
LunulaLaser™ OTC. 
 
5.6. 
OUTCOME OF THE CRITICAL TASK ANALYSIS 
Through the task analysis approach, the critical device analysis was conducted by systematically 
breaking down the device use process into discrete sequences of tasks. Each identified task was 
then analyzed to identify the user interface components involved, the potential use errors (with 
respect to each of potential perceptual, cognitive processing and physical errors, as applicable) 
that users could make and the potential results (consequences and harm) of each of those use 
errors, as well as the mitigation (method of control) in place to prevent or minimize the use error 
from occurring and/or to reduce the severity of potential harm in the event that the use error is still 
made. 
 
Each potential use error was further categorized according to the probability or likelihood of the 
use error the associated hazard occurring, the severity of the potential associated hazard(s) were 
it to occur, and the risk level (Probability/Likelihood X Severity), according to the Tables 1, 2 and 
3, respectively, below. 
 Table 1: PROBABILITY OF OCCURRENCE  
Category  
Rating 
Description 
Frequent 
5 
Likely to occur about once every 100 uses.  
Probable 
4 
A use error/hazard likely to occur about every 10,000 uses or 
about every 2 years of expected use. 
Occasional 
3 
A hazard likely to cause harm every 100,000 uses or only on 
one of two systems over their 10 year expected lives. 
Remote 
2 
A hazard likely to cause harm every 1,000,000 uses or only on 
one of twenty-one systems over their expected lives. 
Improbable 
1 
A use error hazard likely to cause harm every 10 million uses or 
on no currently installed systems within their 10 year expected 
lives (assumes current installed base does not exceed 210 
systems within 10-year period). 
Table 2: SEVERITY 
Rating 
Rating 
Description 
Catastrophic 
5 
Results in death 
Critical 
4 
Results in permanent impairment or life-threatening injury 

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Serious 
3 
Results in injury or impairment requiring medical intervention 
Minor 
2 
Results in injury or impairment not requiring medical 
intervention 
Negligible 
1 
Inconvenience or temporary discomfort 
 
 
 
 
Probability 
Rating 
Severity Rating 
1 
2 
3 
4 
5 
5 
5 
10 
15 
20 
25 
4 
4 
8 
12 
16 
20 
3 
3 
6 
9 
12 
15 
2 
2 
4 
6 
8 
10 
1 
1 
2 
3 
4 
5 
 
The outcome of the critical tasks analysis is contained in Appendix A. 
 
6. 
STUDY PARTICIPANT AND ENVIRONMENTAL DESIGN 
 
6.1. 
SUBJECTS (USERS and CLIENTS) 
 
6.1.1. USER SAMPLE  
 
The study user sample will be representative of the population of intended users of the device 
who are employees at nail salons, beauty salons and spas, fitness and wellness centers, and the 
like.  
 
In defining the device user and the potential impact of the device user characteristics on the user’s 
ability to safely, and effectively, use the device, the following personal characteristics were 
considered and evaluated, with the outcome as follows: 
 
Device User Characteristic 
Outcome of Consideration 
Physical size, strength, and stamina 
Able to lift and carry 23lbs / 10.43 kg 
Physical dexterity, flexibility, and 
coordination 
Able to plug the power cord into the device and an 
electrical outlet; operate the key to turn the device 
on and off; open and close the magnetic door/foot 
platform using the knobs; operate the touchscreen; 
and correctly place the safety glasses on 
themselves and the client. 

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Sensory abilities such as vision, 
hearing, and tactile sensitivity 
Able to read the information on the device screen 
display.  
Cognitive abilities, including memory 
Able to understand the instructions in the 
Installation and Proper Use Reference Guide for 
safe and effective use of the device; able to 
understand when to use the device and how to 
confirm client eligibility. 
Medical condition for which the device is 
being used  
n/a  
Comorbidities 
n/a 
Literacy and language skills 
English language; 5th Grade literacy skills.  
General health status 
n/a 
Mental and emotional state 
Sufficient stability. 
Relevant level of education and health 
literacy 
Able to read at 5th Grade level; aware of client 
eligibility criteria. 
General knowledge of similar types of 
devices 
Not necessary but beneficial. 
Knowledge of and experience with the 
particular device 
n/a 
Ability to learn and adapt to a new device Sufficient ability. 
Willingness and motivation to learn to 
use a new device 
Sufficient willingness and motivation. 
 
In considering these specific characteristics of intended device users that may affect their 
interactions with the device, given the typical profile of the intended users of the LunulaLaser™ 
OTC, it was determined that there did not need to be specific evaluation of potential users within 
any of these specific device user categories.    
 
Additionally, the development and design of the Erchonia LunulaLaser™ OTC and the Installation 
and Proper Use Reference Guide was modelled on the existing Installation and Proper Use 
Reference Guide for Erchonia Corporation’s currently market cleared OTC device, the Erchonia 
Zerona Z6 OTC (K162578; K143007) indicated for: “The Zerona® Z6 OTC device is indicated for 
use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of 

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hips, waist, and thighs.” The user sample in the Human Factors Validation Study whose results 
supported the market clearance for the Zerona Z6 OTC is comparable to that being evaluated in 
the current Human Factors Validation Study; that is, users in the prior study were employees of 
Fitness and Wellness centers and like facilities. 
 
As in this current study, the only training device users received in the human factors evaluation 
of the Zerona Z6 OTC was that contained in the Installation and Proper Use Reference Guide 
and device packaging and labeling.  
 
6.1.1.1. User Sample Eligibility Criteria 
 
To qualify for study participation, the user must satisfy each of the following inclusion criteria and 
none of the exclusion criteria.  
 
Inclusion Criteria 
1. 18 years or older. 
2. Male or female. 
3. Currently employed at a nail salon, beauty salon and/or spa, fitness and wellness centers, or 
the like.   
4. In possession of qualification(s), current licensure(s), certification(s), and/or accreditation(s), 
as applicable, to perform their designated tasks at their place of employment, e.g., 
cosmetology degree, nail technician, esthetician, massage therapist, etc. 
5. Voluntarily signed consent form. 
 
Exclusion Criteria 
1. None. 
 
6.1.1.2. User Sample Size 
 
As per the United States Food and Drug Administration (U.S. FDA) document titled ‘Applying 
Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food 
and Drug Administration Staff’; February 3, 2016, Section 8.1.1 Test Participants (Users), the 
minimum number of 15 subjects is required to be enrolled in and complete this study. The 
minimum sample size of 15 subjects is applicable as the intended actual user population in this 
validation study is a homogenous group of adults who are applicably qualified/licensed/certified/ 

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accredited employees at cosmetology-related facilities such as nail salons, beauty salons and/or 
spas, fitness and wellness centers, or the like.   
 
6.1.1.3. 
User Sample Recruitment  
 
The subject user sample will be recruited from nail salons, beauty salons and/or spas, fitness and 
wellness centers, or the like, in the geographical area within the vicinity of the test location.  
 
A potential candidate who voluntarily signs the informed consent form and subsequently satisfies 
the enrollment criteria will be enrolled as a User in this Human Factors Validation Testing study.   
 
6.1.1.4. 
User Compensation  
 
The user will receive $100 as compensation for participation in this Human Factors Validation 
study. 
 
6.1.2. CLIENT SAMPLE 
 
The client sample will be employees of the study sponsor, Erchonia Corporation, who are not 
involved with the operation of the LunulaLaser OTC, acting as representative clients of the user 
sample. The acting treatment recipient will be instructed to not provide any insight or feedback 
during their participation, as if they were an actual client of the user. 
  
6.1.2.1. Client Sample Recruitment  
 
Representative clients will be recruited from amongst employees of the study sponsor, Erchonia 
Corporation, who are not involved with the operation of the LunulaLaser OTC.   
 
6.1.2.2. 
Client Sample Compensation  
 
Representative clients will not receive any compensation for participation in this Human Factors 
Validations study. 
 
6.2. DEVICE USE ENVIRONMENTS 
 
The Erchonia LunulaLaser™ OTC device use environments are the following non-clinical indoor 
environments: 

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1. Nail Salons 
2. Beauty Salons and Spas 
3. Fitness and Wellness Centers 
4. Comparable facilities 
 
The Erchonia LunulaLaser™ OTC Installation and Proper Use Reference Guide contains specific 
and comprehensive instructions on overall safe and effective use of the device across all intended 
device use environments, specifically as follows: 
 
Safety Information: The Safety Information section contained on pages 4 through 6 of the 
Installation and Proper Use Reference Guide contains specific instructions for device environment 
restrictions and safety factors, as follows: 
 
• 
PRECAUTION (page 5): DO NOT place/operate this device in close proximity (6 inches) to 
other devices that emit frequency.  
• 
PRECAUTION (page 6): Avoid contact with flammable anesthetic with air or with oxygen or 
nitrous oxide. 
• 
PRECAUTION (page 6): This device should be operated in temperatures between 59° to 85° 
F (15° to 29° C), … with relative humidity less than 75% 
• 
PRECAUTION (page 6): Do not position equipment so that in an emergency it is difficult to 
disconnect power cord from electric supply. 
 
Relevant characteristics of the intended device use environments that were considered and 
accommodated during the medical device development and design process to mitigate potential 
conditions and factors that could affect safe and effective use of the Erchonia LunulaLaser™ 
OTC, are the following:  
 
Device User Environment Characteristic 
Mitigation of Consideration 
Proximity to water, liquids and other foreign 
materials that may enter the device 
potentially resulting in damage to the 
device, user and/or treatment recipient. 
• 
 WARNING in Installation and Proper 
Use Reference Guide that states: DO NOT 
permit any foreign materials or liquids to enter 
the device. Take care to prevent any foreign 
materials including, but not limited to, 
inflammables, water, and metallic objects from 

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entering the device. These may cause device 
damage, malfunction, electrical shock, fire, or 
personal injury. To achieve the specified level 
of protection against spilled or splashed 
liquids, unplug the device from the power 
supply and thoroughly dry all exposed 
surfaces of this device and allow to dry 
thoroughly prior to operation. 
• 
 WARNING: Beware of electrocution. 
Do not submerge any part of the device in 
water. This could damage the device or cause 
an electric shock that may lead to serious 
injury or death. Damage resulting from this 
condition is not covered under the warranty.  
Proximity to other devices that emit 
frequency that may interfere with the 
accurate operation of LunulaLaser OTC.  
 PRECAUTION in Installation and Proper 
Use Reference Guide that states: DO NOT 
place/operate this device in close proximity (6 
inches) to other devices that emit frequency. If 
this device causes interference to other 
devices, which can be determined by turning 
the device off and on, you are encouraged to 
try to correct the interference by one of the 
following measures:  
 
Reorient or relocate the receiving device.  
 
Increase the separation between the 
equipment.  
 
Connect the equipment into an outlet on a 
circuit different from that to which the other 
device(s) are connected.  
 
 
 
 
 

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6.3. DEVICE USER INTERFACE  
 
The device user interface is defined as all points of interaction between the user and the device, 
including all elements of the device with which the user interacts (i.e., those parts of the device 
that users see, hear, touch). This includes all sources of information transmitted by the device 
(including packaging, labeling), training and all physical controls and display elements (including 
alarms and the logic of operation of each device component and of the user interface system as 
a whole). 
 
The Erchonia LunulaLaser™ OTC device user interface includes all points of interaction between 
the user and the device, including all elements and components of the device and its operation 
with which the user interacts.  
 
The Erchonia LunulaLaser™ OTC device user interface components and accessories are the 
following: 
1. LunulaLaser™ OTC Device 
2. Power cord 
3. 1 client safety glasses  
4. 2 Keys 
5. Sani-Cloth Germicidal Wipe (Sample pack) 
6. Installation and Proper Use Reference Guide 
 
The device user interface includes the following controls, visual displays, and visual alarms 
and alerts: 
1. Touch Screen that displays the: 
• 
Power Indicator Light 
• 
Start Screen and related icons, Mode Screen and related icons, including Start, Stop, 
Pause, and Resume icons and Time Remaining icons. 
• 
Device Information Screen containing device and manufacturer information.    
2. Pull Knobs/Stops 
3. Door/Foot Platform 
4. Key Switch 
5. Diode Light Indicator 

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6. Magnetic Latch 
7. Handle 
8. Power Inlet/Fuse Holder 
 
The device user interface includes the following labeling: 
 
1. Installation and Proper Use Reference Guide  
2. Box Labeling 
3. Device Labelling 
 
The device user interface is used by the device user under the following conditions and 
sequence of operations: 
1. During initial setup of the device, including opening and unpacking the delivery box 
components. 
2. During establishment of an appropriate device use environment. 
3. During preparation and operation of the device, including plugging the electrical cord into the 
device and an electrical outlet, using the key to power the device on, opening the door/foot 
platform, using the touchscreen to initiate and manage treatment administration, ensuring 
correct fitting of the safety glasses to the client, ensuring correct placement of the subject’s 
treatment foot in the device, and using the key to power the device off.    
4. Understanding all warnings and precautions contained in the Installation and Proper Use 
Reference Guide. 
5. Cleaning of the device and/or device components and accessories between uses. 
 
The device user interface has been designed such that its use is logical and intuitive such that 
correct user actions are facilitated and actions that may result in harm (use errors) are prevented 
or discouraged. Through consideration and initial evaluation of the intended device user 
characteristics, the intended use of the device and thorough review of design specifications and 
operational, output, and functional displays of similar devices already on the market with 
demonstrated safety and efficacy of use by the same intended user population, the logic of 
information display and control actions have been engineered and designed to be consistent with 
users’ expectations, abilities, likely behaviors and experiences with similar devices at any point 
during use.  
 

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Specifically, the following design elements were considered resulting in the associated logical and 
intuitive features of the device user interface:   
Device User 
Interface Design 
Element 
Considered 
Mitigation of Consideration 
Device dimensions 
The device design was targeted to be as small, compact, and lightweight as 
possible, with the following dimensions: 
• Weight: 23lbs / 10.43 kg 
• Height:16in/40 cm  
• Width:12in/30 cm  
• Depth: 10in/25.40cm (38 cm with platform extended) 
The LCD screen 
(graphic user 
interface) that 
provides 
information to the 
user. 
The LCD screen displays information pertaining to initiating, pausing, 
resuming, and stopping treatment; treatment time remaining; and device/ 
manufacturer information.   
 
To ensure that readability is always optimal, the LCD screen remains lit 
throughout the treatment administration process.  
Components that 
the user attaches 
to the device, i.e., 
power cord and 
key.  
Each of these components and the locations on the LunulaLaser™ OTC to 
which they are attached/inserted have been designed to be intuitive to 
determine and easy to locate, access and use. The design took into 
consideration the design of other similar devices currently on the OTC 
market. Additionally, the Installation and Proper Use Reference Guide has 
been clearly designed using both text and related labelled images to 
demonstrate each step of connection, removal, and operation, as 
applicable, of each individual component to the device, when and as 
necessary. 
Hardware 
components to 
control device 
operation. 
Following correct attachment of all components to the LunulaLaser™ OTC 
device, the user operates the device using the key and the icons on the 
touchscreen on the device interface. The key and the touchscreen 
placement were designed with consideration of intuitive use and ease of 
use restricted solely to the tasks the user must perform to safely, and 
effectively, activate and operate the device. The key is easily inserted into 
the keyhole and turns without effort to power the device on and off. The 

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icons on the touchscreen are activated by gentle touch with the finger and 
encompass the Start, Stop, Pause, and Resume icons, and the Time 
Remaining icon. 
Each icon activation action is verified by the corresponding result being 
displayed on the touchscreen. This information is also clearly explained 
using text and images in the Installation and Proper Use Reference Guide.  
Safety Glasses 
The LUNULALASER™ 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 of time could prove to be damaging. To ensure there is no 
possible instance of residual effect, a pair of specialty safety glasses for use 
by the client during treatment is provided in the device packaging. The 
safety glasses, sufficiently and effectively block the laser light spectrum at 
OD 2+ @ 635nm, OD 0.75 @ 405nm VLT60. 
 
Additionally, the following warning is included in the Installation and Proper 
Use Reference Guide: 
 WARNING: The client should always be correctly fitted with the safety 
glasses provided before turning on the laser and doing any treatment.  
 
Furthermore, Step 6 of the LunulaLaser™ OTC Treatment Protocol on 
page 17 of the Installation and Proper Use Reference Guide reads as 
follows: “Have your client put on the safety glasses…”  
Logic of the overall 
user-system 
interaction, 
including how, 
when, and in what 
form information 
(i.e., feedback) is 
provided to the 
user. 
Set-up and use of the Erchonia LunulaLaser™ OTC device is designed to 
be inherently logical and sequential. Information, including visual 
confirmation via text and lights of user tasks performed are provided in real-
time on the LCD and touch screen. These operations and interactions have 
also been designed with consideration of the design of comparable devices 
presently on the market. 

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Packaging and 
labeling, including 
the Installation and 
Proper Use 
Reference Guide.  
Consideration in the design of the packaging and labeling materials was 
given to ensuring direct compatibility and correspondence between the 
sequential order of information presented in the Installation and Proper Use 
Reference Guide and the sequential order of device setup and operation to 
be performed by the user. All instructional materials contain related text and 
images for all operations, as applicable. Attention was made to ensuring all 
potential warnings, cautions and other potential hazards and risks that may 
potentially occur are included in the Reference Guides, as well as cleaning, 
troubleshooting, maintenance, and warranty information. As with the other 
elements of the design and development of the LunulaLaser OTC, 
consideration was given to the layout and content of Reference Guides/User 
Manuals for other comparable devices currently on the market.    
 
6.4. STUDY OBSERVER 
 
The Study Observer is an Erchonia Corporation employee who is suitably qualified, trained and 
experienced in conducting Human Factors Validation Testing and is specifically trained to all 
aspects of the set-up, start-up and use of the Erchonia LunulaLaser™ OTC; and to the information 
contained in the Installation and Proper Use Reference Guide, and device and package labeling.    
 
The Study Observer’s sequential role in this study is to: 
 
(i) 
conduct the informed consent process with the user. 
(ii) conduct the study qualification evaluation with the user.  
(iii) observe the user’s performance across each of the critical tasks associated with the process 
of using the LunulaLaser™ OTC from receipt of the packaged device through to operation 
and use of the device to administer a treatment, and to note his or her observations, including 
observations of use problems and errors and close calls, throughout the process on the 
respective Observation Forms.  
 
The Study Observer is trained not to provide any guidance to the user through this process 
or to answer any questions, simply to observe and to record those observations, unless 
intervention becomes necessary for safety.  
 
(iv) conduct a post-test debriefing interview to collect the user’s perspectives to supplement the 
observer’s observations, including attaining the user’s subjective assessment of any use 

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difficulties experienced throughout the process of setting up and operating the device; 
gathering specific feedback on each critical task; and investigating all use difficulties, errors 
and close calls observed and noted by the Study Observer during the test phase.   
 
(v) assess the user’s understanding of the essential information contained in the Installation and 
Proper Use Reference Guide, and packaging and device labeling through administration of 
a knowledge task questionnaire. 
 
7. 
STUDY PROCEDURE 
 
7.1. 
STUDY MATERIALS 
 
The following materials will be employed during this Human Factors Validation Testing. 
 
(i) 
Erchonia LunulaLaser™ OTC Installation and Proper Use Reference Guide, contained in 
Appendix A. 
(ii) Box Label for the Erchonia LunulaLaser™ OTC contained in Appendix C. 
(iii) User Study Eligibility Evaluation Case Report Forms contained in Appendix D. 
(iv) Device Use Study Observer Observation Record Form contained in Appendix E. 
 
The Device Use Study Observer Observation Record Form will be used by the Study 
Observer to record his or her observations pertaining to the user’s ability to correctly and 
safely set-up, start-up and operate the Erchonia LunulaLaser™ OTC.  
 
(v) Post-Test Debriefing Interview Record Form contained in Appendix F. 
 
The Post-Test Debriefing Interview Record Form includes specific assessment of the user’s 
perspectives of the device operation, including attaining the user’s subjective assessment of 
any use difficulties experienced throughout the process of setting up and operating the 
device; on each critical task; and regarding the specific use difficulties, errors and close calls 
observed and noted by the Study Observer during the test phase using open-ended and 
neutrally worded questions.   
 
(vi) Knowledge Task User Questionnaire contained in Appendix G. 
 
The Knowledge Task User Questionnaire includes specific verbal questioning and 
assessment of the user’s understanding of the information contained in the Installation and 

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Proper Use Reference Guide, and device and packaging labeling using open-ended and 
neutrally worded questions. This includes assessment of the user’s understanding of the 
indication for use; of how to assemble and operate the Erchonia LunulaLaser™ OTC; of all 
critical tasks and use scenarios; and of the specific warnings and cautions pertaining to use 
of the Erchonia LunulaLaser™ OTC.   
 
(vii) Subject User Information and Consent Form contained in Appendix H. 
 
7.2. 
STUDY PROCEDURE PROTOCOL  
 
The following procedure protocol will be implemented sequentially and fully for each enrolled user 
and treatment recipient, as applicable. 
 
 
7.2.1. SIGNING OF INFORMED CONSENT 
The Study Observer will review the informed consent form with the potential candidate and 
answer any questions. A candidate who subsequently voluntarily signs the informed consent form 
will be enrolled as a user in the study and receive a unique de-identified subject ID. The Subject 
ID will comprise the Study Observer’s first and last name initials followed by a 2-digit number from 
01 onwards determined by the user’s order of sequential enrollment. For example, the fifth user 
to be enrolled in this study will have a unique de-identified subject ID of TS05. 
 
7.2.2.    ELIGIBILITY EVALUATION  
7.2.2.1. User 
The Study Observer conducts the user eligibility evaluation to confirm that the user fully qualifies 
to take part in the study. 
 
7.2.3. PROVISION OF STUDY DEVICE 
The user is provided with the Erchonia LunulaLaser™ OTC in its intended packaging that also 
contains the Installation and Proper Use Reference Guide exactly as is intended to be supplied 
following FDA market clearance. The user is instructed to open the packaging and prepare the 
device for use exactly as they would if they were they to receive it at their place of employment. 
 
N.B.: There will be no participant training in preparation or use of the device in this Human Factors 
Validation Testing study as it is not intended that users receive any training once the device has 
market clearance. It is intended that the user will receive delivery of the device in its packaging at 

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the place of employment. The user will need to set-up and operate the device based upon the 
information provided with the packaging, and therefore, this Human Factors Validation Testing 
study will also not implement user training to optimally simulate intended use of the Erchonia 
LunulaLaser™ OTC in real life. Additionally, users will be left to work out how to operate the 
Erchonia LunulaLaser™ OTC and to administer a treatment as independently and naturally as 
possible, without interference, influence, or instruction from the Study Observer, including whether 
or not the user chooses to read the instructional materials provided including the Installation and 
Proper Use Reference Guide. 
 
7.2.4. USER USE OF DEVICE 
The user is instructed to operate and use the device to administer treatment to the client following 
the exact process he or she would follow as if the device had just been received via delivery at 
his or her place of employment.  
 
As this process is ongoing, the Study Observer will observe the user’s performance from opening 
of the packaged device through to operation and use of the device, or otherwise to as far as the 
subject is able to complete the process, and will note his or her observations, including 
observations of use difficulties/problems, errors, and close calls on the Device Use Study 
Observer Observation Record Form (Appendix E). 
 
The Study Observer will not provide any verbal, written or any other form of guidance or 
assistance to the user throughout this process, and although the Study Observer will record any 
questions asked by the user during this process, he or she will not answer any questions the user 
may ask or otherwise interfere in the process, unless intervention becomes necessary for safety 
reasons.  
 
7.2.5. POST-TEST DEBRIEFING INTERVIEW 
Once the user indicates that he or she has completed the device use and treatment application 
process, the Study Observer will conduct the Post-Test Debriefing Interview (Appendix F). The 
Study Observer will record verbatim the user’s responses to each question but will otherwise not 
react to the user’s responses. The Study Observer will not explain or reword any of the questions 
in the Knowledge Task Patient User Questionnaire and will not provide any guidance or feedback 
regarding the user’s responses in any manner.  
 
 

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7.2.6. KNOWLEDGE TASKS EVALUATION  
The knowledge tasks evaluation will take place once the Post-Test Debriefing Interview is 
complete. The knowledge tasks evaluation commences with the Study Observer requesting that 
the user read through the Installation and Proper Use Reference Guide and all other labeling 
information contained on the device and the packaging regardless of whether or not he or she did 
so during the use evaluation study component. The Study Observer will not point out any specific 
information in any of these materials to be read or noted, and although the Study Observer will 
record any questions asked by the user during the material review process, he or she will not 
answer any questions the user may ask or otherwise interfere with the process in any manner.  
 
Once the user indicates that he or she has completed reading the supplied materials, the Study 
Observer will administer the Knowledge Task Patient User Questionnaire (Appendix G). The 
Study Observer will record verbatim the user’s responses to each question but will otherwise not 
react to the user’s responses. The Study Observer will not explain or reword any of the pre-
established questions in the Knowledge Task Patient User Questionnaire and will not provide any 
guidance or feedback regarding the user’s responses in any manner.  
 
Following completion of the knowledge tasks evaluation, the user’s participation in the study is 
complete.    
 
8. 
REGULATORY AND ETHICAL CONSIDERATIONS 
 
8.1. 
DATA MANAGEMENT 
8.1.1. Data Administration  
For each enrolled user, the Study Observer will be the only individual to record information on the 
study record forms and only the required data elements will be recorded. There will be no 
identifying information recorded that could potentially connect an individual user’s data record to 
the individual. Unique de-identified codes will be used on each user’s record forms.  
 
The recorded data will only be used for the purposes of evaluating the objectives of this study. 
The sole parties who will have access to the record forms and the study data will be the Study 
Observer, the study Sponsor and the study analyst. Access to the record forms and data will not 
be given to outside parties at any time during the data collation and analysis process or in the 
future for any reason.  

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8.1.2. Compliance Statement 
The Study Observer will perform the study in accordance with this protocol. Collection and 
recording of data will be accurate and will ensure the privacy, health, and welfare of users during 
and after the data collection process.  
 
8.2. 
INFORMED CONSENT 
8.2.1. Informed Consent 
This Human Factors Validation Testing study will operate under appropriate Investigational 
Review Board (IRB) approval and will meet Health Insurance Portability and Accountability Act 
(HIPAA) Privacy Requirements. Prior to study enrollment, each user partaking in the study will be 
required to voluntarily sign the study informed consent form following review of the form with the 
Study Observer. The informed consent form for this study is contained in Appendix H. 
 
8.2.2. Confidentiality 
All data and record forms generated during this study will be kept confidential in accordance with 
HIPAA regulations on subject privacy. The Study Observer will not use the data and record forms 
for any purpose other than conducting the study. Coded de-identifiers will be used for all data 
entries. 
 
8.3. 
RISK ASSESSMENT 
8.3.1. Potential Risks of Participation  
The only potential risk to subjects (users) in this study is breach of privacy and confidentiality. The 
application of a de-identified coding system to record subject data has been established to 
minimize this risk.   
 
8.3.2. Potential Benefits of Participation 
There is no direct benefit to the subject (user) from participation in this Human Factors Validation 
Testing study. There may be benefit to potential future users of the device and to individuals with 
diagnosed toenail onychomycosis who may be potential future recipients of treatment with the 
Erchonia LunulaLaser™ OTC in the user settings.  
 
8.3.3. Risk-Benefit Assessment 
The Risk-Benefit assessment reveals no negatives in conducting this Human Factors Validation 
Testing.   

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9. 
SAFETY MANAGEMENT 
9.1. USER DIFFICULTIES AND ERRORS  
 
All observed and reported user difficulties and errors will be recorded and evaluated as part of 
the study procedural protocol and consistent with the goal of this Human Factors Validation 
Testing. 
 
9.2. ADVERSE EVENTS REPORTING 
While it is not anticipated that any adverse events will occur during this Human Factors Validation 
Testing, any and all potential adverse events observed or reported will be recorded on the 
applicable record forms and subsequently evaluated and handled in accordance with the study 
site, IRB and FDA reporting and handling policies and requirements.  
 
10. PUBLICATION 
The outcome of this Human Factors Validation Testing will be written up for the purpose of 
inclusion in a 510(k) submission to the FDA seeking regulatory market clearance for OTC use of 
the Erchonia LunulaLaser™ OTC. In the event of inclusion of the outcome of this study in a 
potential future publication, there will be no identifiable information for any individual subject (user) 
and no individual case studies will be profiled. 
 
11. ANALYSIS OF HUMAN FACTORS VALIDATION TESTING  
 
11.1. PRIMARY ANALYSIS 
 
A subject user in this study will be considered as either a study ‘pass’ or a study ‘fail,’ defined as 
follows: 
 
• 
Study Pass: A subject user who satisfactorily completes both the device setup and treatment 
procedure will be determined a Study Pass. 
 
• 
Study Fail: A subject user who does not satisfactorily complete either one or both of device 
setup and/or treatment procedure will be determined a Study Fail. 
 

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11.2. QUALITATIVE ANALYSIS 
 
The results of the Human Factors Validation Testing will be analyzed qualitatively to determine if 
the design of the device and all associated instructional materials and labeling require 
modification to reduce any identified use-related risks to acceptable levels. 
 
11.2.1. Root Cause Analysis 
 
Observational and knowledge task data will be aggregated with the debriefing interview data and 
analyzed in detail to determine the root cause of any identified and/or reported use difficulties 
and/or errors, including close calls. The analysis will include evaluation of how the use errors or 
problems occurred within the context of device use, including the specific aspect of the user 
interface that caused problems for the user. 
 
The root causes of all use errors and problems will be considered with respect to the associated 
risks to ascertain the potential for resulting harm and to consequently determine the need for and 
priority of implementing additional risk management measures. 
 
11.2.2. Implementation of User Interface and Labeling Modifications 
 
In consideration of each risk identified through the root cause analysis as having the potential for 
resulting harm, user interface modifications and labeling and any other necessary risk 
management measures will be determined and implemented with the goal of reducing the risk to 
acceptable levels. This includes consideration of any suggestions for modifications to address 
used problem and/or errors made by the users during the post-test debriefing interview.  
 
11.2.3. 
Retesting 
 
If indicated by the extent of user interface modifications and risk management strategies 
implemented, retesting may be performed to specifically address the aspects of the user interface 
that led to the use problems and errors and to evaluate the modified user interface elements to 
assess the risk management measures implemented in reducing risks to acceptable levels 
without introducing any new unacceptable risks. 
 
11.2.4. Residual Risk Evaluation  
All residual risks identified after user interface modification are finalized will be analyzed to 
determine if and where applicable, how, each can be reduced or eliminated.