Treatment With the Evoke System for Facial and Submental Laxity
Phase: NA
Conditions: Laxity; Skin
Sponsor: InMode MD Ltd.

 
Treatment with the Evoke System for Facial and Submental Laxity  
Protocol No: DO609886A 
SIRB ID:                     
Rev. Date: 29 Oct. 20 
 
 
 
STUDY NAME: TREATMENT WITH THE EVOKE SYSTEM FOR FACIAL AND 
SUBMENTAL LAXITY 
 
DOCUMENT DATE: October 29. 2020 
 
IDENTIFIERS:  NCT04719013  
 
PROTICOL ID: DO609886A  
 

 
Treatment with the Evoke System for Facial and Submental Laxity  
Protocol No: DO609886A 
SIRB ID:                     
Rev. Date: 29 Oct. 20 
 
 
 
Study Name:  
Treatment with the Evoke System for Facial and 
Submental Laxity 
 
Protocol No.:        
 
Revision No.:  
1 
 
Sponsor: 
InMode Ltd. 
Tabor House  
Industrial Park South  
Yokneam 20692 ISRAEL 
POB 44 
Tel +972-4-9097309 
Fax +972-4-9096310 
 
 

 
Treatment with the Evoke System for Facial and Submental Laxity  
Protocol No: DO609886A 
SIRB ID:                     
Rev. Date: 29 Oct. 20 
 
1. Protocol Synopsis 
Study Title 
Treatment with the Evoke System for Facial and Submental Laxity  
Protocol No 
DO609886A 
Sponsor 
InMode Ltd.  
Investigational 
Product 
Evoke (K191855) 
Study Design 
Prospective, open label clinical study. 
Study Sites 
#1-, #2-, #3-, #4-, #5-  
Patient Population 
and Sample Size 
Subjects aged 35-75, healthy adults with visible signs of aging, seeking skin laxity 
treatments.  
Approximately 15 subjects will be enrolled per site  
Treatment areas include face, under chin (submental) 
Study Duration 
Study duration for each subject is approximately 10 months (including screening, three 
treatments once in 2 weeks and 3 follow-up visits at 1m (except site #3), 3 months and 6 
months post last treatment.  
Overall study duration will be approximately 14 months, depending on the subject 
recruitment rate. 
Study Objectives 
 
The aim of the study is to evaluate the efficacy, patient comfort, and patient satisfaction 
after Evoke treatment for face and submental area 
Primary Objective 
1. Evaluate improvement in skin appearance comparing pre and at 1 month (except 
site #3), 3 months and 6 months post last treatment photographs (as assessed by 
blinded investigators) 
2. Evaluate Improvement in skin appearance using 3D Photographic analysis at 
1month (except site #3), 3 months and 6 months follow up visits and compared to 
the baseline. 
Secondary 
Objectives 
1. Evaluate Investigator assessment of the skin appearance improvement comparing 
pre and post treatment using 0 - 4 -points Likert scale at 1month (except site #3), 
3 months and 6 months follow up visits. 
2. Evaluate Subject assessment of improvement and satisfaction using 0 - 4 -points 
Likert scale at 1month (except site #3), 3 months and 6 months follow up visits.  

 
Treatment with the Evoke System for Facial and Submental Laxity  
Protocol No: DO609886A 
SIRB ID:                     
Rev. Date: 29 Oct. 20 
 
3. Optional: Evaluate histological changes to treatment area skin taken at 3M FU 
versus baseline. (except site #3) 
 Efficacy Endpoints  
1. Improvement in skin appearance comparing pre and at 1 month (except site #3 ), 
3 months and 6 months post last treatment photographs (as assessed by blinded 
investigators): 
• 
Success is defined by correct identification of the pre and post treatment photos 
of patients completed the treatment at 1 month (except site #3 ), 3 months and 6 
months post treatment. 
• 
At least 2 out of 3 blinded evaluators should agree on the assessment. 
2. 3D Photographic analysis will be conducted at 1 month (except site #3 ),, 3 
months and 6 months follow up visits and compared to the baseline. 
3. Investigator assessment of the skin appearance improvement comparing pre and 
post treatment using 0 - 4 -points Likert scale at 1 month (except site #3 ),  3 
months and 6 months follow up visits: 
• 
4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate 
improvement; 1 = Slight improvement; 0 = No difference 
4. Improvement assessment will be performed independently by the subject himself 
4 points Likert scale questionnaire (Global Aesthetic Improvement Scale), as 
follows: 
• 
4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate 
improvement; 1 = Slight improvement; 0 = No difference. 
5. Subject assessment of satisfaction will be filled out by subjects using a 5-points 
Likert scale, as follows: 
• 
 +2 = Very satisfied; +1 = Satisfied; 0 = Indifferent; -1 = Disappointed; -2 = Very 
disappointed. 
6. Optional: Positive changes in histologic evaluation: up to 5 subjects will undergo 
biopsies of the treated area for histology at baseline and at 3M follow-up visit. 
Histological sections will be stained using elastin, H&E and other collagen specific 
stains. (except site #3) 
Safety Endpoint 
• 
Observation, assessment and recording of adverse events. 
• 
Discomfort Level assessment - subject will be asked to rate discomfort during the 
procedure. Discomfort will be assessed based on the Numerical Scale Response 
(NSR).  The subject will be presented a scale and asked to make a mark along the 
scale. The subject will be asked to rate discomfort from 0 to 10, with 0 equaling no 
discomfort and 10 equaling the worst possible discomfort. A number is obtained 
by measuring up to the point the subject has indicated. (Appendix 3 – Discomfort 
Assessment) 
• 
Evaluations will be done immediately after treatments and at all follow-up visit. 
The frequency, severity and causality of all adverse events will be recorded. 

 
Treatment with the Evoke System for Facial and Submental Laxity  
Protocol No: DO609886A 
SIRB ID:                     
Rev. Date: 29 Oct. 20 
 
Statement of Compliance 
This study will be conducted in accordance with the Code of Federal Regulations on the Protection of 
Human Subjects (45 CFR Part 46), any other applicable US government research regulations, and 
institutional research policies and procedures. The Principal Investigator will assure that no deviation 
from, or changes to the protocol will take place without prior agreement from the sponsor and 
documented approval from the Institutional Review Board (IRB), except where necessary to eliminate an 
immediate hazard(s) to the trial participants. 
 
 
 
 
 
 
 
 
 

 
Treatment with the Evoke System for Facial and Submental Laxity  
Protocol No: DO609886A 
SIRB ID:                     
Rev. Date: 29 Oct. 20 
 
TABLE OF CONTENTS 
1. 
PROTOCOL SYNOPSIS .................................................................................................... 3 
2. 
INTRODUCTION & STUDY RATIONALE .......................................................................... 9 
3. 
DEFINITIONS, ACRONYMS AND ABBREVIATIONS ....................................................... 9 
4. 
DEVICE DESCRIPTION ....................................................................................................10 
5. 
STUDY OBJECTIVES ......................................................................................................10 
6. 
STUDY ENDPOINTS ........................................................................................................11 
6.1 
Efficacy Endpoints ......................................................................................................................................... 11 
6.2 
Safety Endpoint ............................................................................................................................................. 11 
7. 
STUDY POPULATION ......................................................................................................12 
7.1 
General Considerations ................................................................................................................................. 12 
7.2 
Subject Withdrawal and Replacement .......................................................................................................... 12 
7.3 
Subject Identification .................................................................................................................................... 12 
7.4 
Inclusion Criteria ........................................................................................................................................... 12 
7.5 
Exclusion criteria ........................................................................................................................................... 13 
8. 
STUDY PROCEDURES ....................................................................................................14 
8.1 
Screening and Baseline (Visit 1) .................................................................................................................... 14 
8.2 
Treatment (visits 1-3) .................................................................................................................................... 14 
8.3 
Follow up visits (Visits 4, 5 and 6) ................................................................................................................. 16 
9. 
ADVERSE EVENTS REPORTING ....................................................................................17 
9.1 
Definitions ..................................................................................................................................................... 17 
9.2 
Anticipated Adverse Events in this Clinical Evaluation .................................................................................. 18 
9.3 
Precautions to Minimize Complications ........................................................................................................ 18 
9.4 
Investigator Records ...................................................................................................................................... 18 

 
Treatment with the Evoke System for Facial and Submental Laxity  
Protocol No: DO609886A 
SIRB ID:                     
Rev. Date: 29 Oct. 20 
 
9.5 
Investigator Reporting of AEs ........................................................................................................................ 19 
10. 
REGULATORY ASPECTS ............................................................................................19 
10.1 
Institutional Review Board ....................................................................................................................... 19 
10.2 
Informed Consent ..................................................................................................................................... 19 
10.3 
Protocol and Informed Consent Changes ................................................................................................. 20 
10.4 
Product Supply and Maintenance ............................................................................................................ 20 
10.5 
Privacy of Personal Data ........................................................................................................................... 20 
10.6 
Confidentiality Statement ........................................................................................................................ 20 
11. 
DOCUMENTATION .......................................................................................................20 
11.1 
Case Report Forms (CRFs) ......................................................................................................................... 20 
11.2 
Maintenance and Retention of Records ................................................................................................... 21 
11.3 
Reports ..................................................................................................................................................... 21 
12. 
MONITORING PLAN ....................................................................................................21 
12.1 
General Considerations ............................................................................................................................ 21 
12.2 
On-Site Visits............................................................................................................................................. 22 
12.3 
Site Initiation Meeting .............................................................................................................................. 22 
12.4 
Adverse Event Reporting and Follow-up .................................................................................................. 22 
12.5 
Site Closure Visit ....................................................................................................................................... 22 
13. 
RISK/BENEFIT ANALYSIS ...........................................................................................22 
13.1 
Expected Risks: ......................................................................................................................................... 22 
13.2 
Expected Benefits: .................................................................................................................................... 23 
13.3 
Conclusion: ............................................................................................................................................... 23 
14. 
DATA ANALYSIS .........................................................................................................23 
14.1 
Analysis Sets ............................................................................................................................................. 23 
14.2 
Statistical Analysis .................................................................................................................................... 23 
15. 
DATA MANAGEMENT PLAN .......................................................................................23 

 
Treatment with the Evoke System for Facial and Submental Laxity  
Protocol No: DO609886A 
SIRB ID:                     
Rev. Date: 29 Oct. 20 
 
 
 
 
 
 
 
 
 
 
 
 

 
Treatment with the Evoke System for Facial and Submental Laxity  
Protocol No: DO609886A 
SIRB ID:                     
Rev. Date: 29 Oct. 20 
 
2. Introduction & Study Rationale  
The human skin aging process is characterized by thinning dermis, atrophy of the extracellular matrix, 
and reduced collagen synthesis. Overwhelming epidemiologic and laboratory evidence indicates that 
sun exposure and other sources of UV radiation play a major role in causing the undesirable skin 
changes of fine and coarse wrinkles, roughness, laxity, mottled pigmentation, actinic lentigines, actinic 
keratoses, leathery texture/coarseness, scaling/xerosis, shallowness, and telangiectasia1. 
Although facelift surgical procedure remains an extremely effective and popular method to reduce static 
rhytids, there has been a dramatic paradigm shift toward non-surgical skin tightening and rejuvenation 
techniques, as patients seek to achieve skin tightening with no or minimal downtime procedures. 
Non-ablative energy treatments for skin laxity and rhytides have grown rapidly in the last 10 years. Mid-
infrared lasers were initially studied for potential efficacy in skin tightening, but the results were modest 
and, additionally, the devices could often not be used on darker skin types due to risk of discoloration 
and scarring following absorption of energy by the chromophore melanin2. 
Radiofrequency (RF) devices have been reported to achieve modest clinical efficacy in skin tightening 
without many of the limitations of other energy devices, and may therefore represent an ideal 
treatment option for non-invasive skin tightening3-5. 
However, most RF treatments are administrated by the operator hence, this treatment is time 
consuming and causes operator fatigue reducing the most effective outcome of the treatment. Evoke 
device allowing hands free procedure that eliminates operator dependency factor.  
The Evoke device is a non-invasive system based on radiofrequency (RF) energies. The Evoke provides a 
non-invasive approach to achieve a desired aesthetic effect (skin tightening and wrinkle reduction). The 
system is designed to enable an automatic, hands-free, full facial treatment that is based on a 
predefined user protocol. In addition, the system incorporates a skin-temperature control into the 
protocol, enabling accurate, stable and safer treatment. 
This prospective study is intended to evaluate the efficacy and safety of Evoke system using radio 
frequency for wrinkles reduction and skin tightening. Aging is associated with a decrease in collagen 
turnover due to a decrease in fibroblasts and elastin.  The degradation and disorganization of elastin 
fibers contribute to skin laxity and wrinkles. We may be able to see improvement in histology. 
3. Definitions, Acronyms and Abbreviations  
RF -  
 
 
 
Radiofrequency 
AE - 
 
 
 
Adverse Events 
SAEs -   
 
 
Serious Adverse Events  
UADEs -  
 
 
Unanticipated Adverse Device Effects  

 
Treatment with the Evoke System for Facial and Submental Laxity  
Protocol No: DO609886A 
SIRB ID:                     
Rev. Date: 29 Oct. 20 
 
4. Device Description 
The Evoke Platform employs Radio-frequency (RF) technology for various aesthetic applications. 
The Evoke System with the Cheek and Chin Applicators is a hands-free medical aesthetic device using RF 
energy for the treatment of selected medical conditions such as relief of minor muscle aches and pain, 
relief of muscle spasm, temporary improvement of local blood circulation. 
RF energy does not cause any thermal damage to the treated skin. The System provides individual 
adjustment of RF power to achieve maximum efficiency, safety and comfort for each patient. The 
System provides enhanced safety while minimizing possible side effects by constantly monitoring RF 
parameters.  
The System incorporates the following safety features. All personnel operating the System should be 
familiar with these features. 
• 
System has unique password to avoid device operation by non-authorized personnel. 
• 
An audible tone indicates energy activation. 
• 
Special audible tone will be activated in case of bad coupling of one of the applicators. 
• 
During activation, the system performs a self-test of the hardware. 
• 
Hardware is tested every 1 msec. to ensure proper operation of electrical circuits. 
• 
Skin surface temperature is monitored during the treatment. RF energy delivery is 
terminated when skin temperature accidentally reaches the Cut-Off level. 
• 
System starts at a low setting. 
5. Study Objectives 
The aim of the study is to evaluate the efficacy, patient comfort and patient satisfaction after Evoke 
treatment. 
Primary Objective: 
1. 
Evaluate improvement in skin appearance comparing pre and at 1 month (except site #3), 3 
months and 6 months post last treatment photographs (as assessed by blinded 
investigators) 
2. 
Evaluate Improvement in skin appearance using 3D Photographic analysis at 1 month 
(except site #3), 3 months and 6 months follow up visits and compared to the baseline. 
Secondary Objective: 
1. 
Evaluate Investigator assessment of the skin appearance improvement comparing pre and 
post treatment using 0 - 4 -points Likert scale at 1 month (except site #3), 3 months and 6 
months follow up visits. 

 
Treatment with the Evoke System for Facial and Submental Laxity  
Protocol No: DO609886A 
SIRB ID:                     
Rev. Date: 29 Oct. 20 
 
2. 
Evaluate Subject assessment of improvement and satisfaction using 0 - 4 -points Likert scale 
at 1 month (except site #3), 3 months and 6 months follow up visits.  
3. 
Optional: Evaluate histological changes to treatment area skin taken at 3M FU versus 
baseline. (except site #3) 
6. Study Endpoints 
6.1 Efficacy Endpoints 
1. Improvement in in skin laxity comparing pre and at 1 month (except site #3), 3 months and 6 
months post last treatment photographs (as assessed by blinded investigators): 
• 
Success is defined by correct identification of the pre and post treatment photos of patients 
completed the treatment at 1 month (except site #3), 3 months and 6 months post treatment. 
• 
At least 2 out of 3 blinded evaluators should agree on the assessment. 
2. 3D Photographic analysis will be conducted at 1 month (except site #3), 3 months and 6 months 
follow up visits and compared to the baseline. 
3. Investigator assessment of the skin appearance improvement comparing pre and post 
treatment using 0 - 4 -points Likert scale at 3 months and 6 months follow up visits: 
• 
4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 
= Slight improvement; 0 = No difference 
4. Improvement assessment will be performed independently by the subject himself 4 points Likert 
scale questionnaire (Global Aesthetic Improvement Scale), as follows: 
• 
4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 
= Slight improvement; 0 = No difference. 
5. Subject assessment of satisfaction will be filled out by subjects using a 5-points Likert scale, as 
follows: 
• 
 +2 = Very satisfied; +1 = Satisfied; 0 = Indifferent; -1 = Disappointed; -2 = Very disappointed. 
6. Optional: Positive changes in histologic evaluation: up to 5 subjects will undergo biopsies of the 
treated area for histology at baseline and at 3M follow-up visit. Histological sections will be 
stained using elastin, H&E and other collagen specific stains. 
6.2 Safety Endpoint 
• 
Observation, assessment and recording of adverse events. 
• 
Discomfort Level assessment - subject will be asked to rate discomfort during the procedure. 
Discomfort will be assessed based on the Numerical Scale Response (NSR).  The subject will be 
presented a scale and asked to make a mark along the scale. The subject will be asked to rate 
discomfort from 0 to 10, with 0 equaling no discomfort and 10 equaling the worst possible 
discomfort. A number is obtained by measuring up to the point the subject has indicated. 
(Appendix 3 – Discomfort Assessment) 
• 
Evaluations will be done immediately after treatments and at all follow-up visit. The frequency, 
severity and causality of all adverse events will be recorded.  

 
Treatment with the Evoke System for Facial and Submental Laxity  
Protocol No: DO609886A 
SIRB ID:                     
Rev. Date: 29 Oct. 20 
 
• 
Number, severity and type of any adverse event recorded throughout the course of the study. 
7. Study Population 
7.1 General Considerations 
The study will recruit approximately 15 subjects per site, between the ages of 35-75, healthy adults with 
visible signs of aging, seeking skin laxity treatments.  
Treatment areas include face, under chin 
Eligible subjects will be screened. Investigators will screen subjects based on the inclusion/exclusion 
criteria described below after a written informed consent is signed. 
7.2 Subject Withdrawal and Replacement 
Subjects enrolled in the study can discontinue their participation at any time for any reason without 
prejudice or reduction in the quality of their medical care.  The investigators or sponsor can terminate a 
subject's participation in this study to protect the subject's health or if the subject fails to follow 
directions resulting in noncompliance to study procedures.  Subjects who withdraw or are terminated 
from the study may be replaced to ensure approximately 15 subjects (per site) have completed the 
study.  Subjects who fail to complete the treatment will be replaced and will not be evaluable. 
7.3 Subject Identification 
A unique subject identification code will be assigned when an individual subject is qualified for 
enrolment. 
Subject identification details will be coded using subject’s initials, subject case number and site number. 
Subject initials will be composed of the first letter of given name and first letter of last name (for 
example, AS for Adam Smith) and a three-digit sequential number. The investigator will complete 
subject identification on a confidential site log, which will be used for the purposes of traceability. 
An example is provided below: 
AS 101 
In any case, other identification details (i.e. full names, phone numbers, etc,) will not be filled in any way 
in the CRF. The identification log will be kept in the study file only. 
7.4 Inclusion Criteria 
- 
Signed informed consent to participate in the study. 
- 
Female and male subjects,  35 and  75 years of age at the time of enrolment 

 
Treatment with the Evoke System for Facial and Submental Laxity  
Protocol No: DO609886A 
SIRB ID:                     
Rev. Date: 29 Oct. 20 
 
- 
If female, not pregnant, lactating and must be either post-menopausal, surgically sterilized, or using 
a medically acceptable form of birth control at least 3 months prior to enrolment (i.e., oral 
contraceptives, contraceptive implant, barrier methods with spermicide or abstinence). 
- 
In addition, negative urine pregnancy test as tested before each treatment and at the last visit for 
women with childbearing potential (e.g. not menopause). 
- 
General good health confirmed by medical history and skin examination of the treated area. 
- 
Willing to have photographs and images taken of the treated areas to be used de-identified in 
evaluations, publications and presentations.  
- 
The patients should be willing to comply with the study procedure and schedule, including the 
follow up visit, and will refrain from using any other aesthetic treatment methods for the last 6 
months and during the entire study period.  
7.5 Exclusion criteria 
- 
Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body. 
- 
Permanent implant in the treated area such as metal plates and screws, silicone implants or an 
injected chemical substance, unless deep enough in the periostal plane. 
- 
Current or history of skin cancer, or current condition of any other type of cancer, or premalignant 
moles. 
- 
Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and 
liver or kidney diseases. 
- 
Pregnancy and nursing.    
- 
Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of 
immunosuppressive medications. 
- 
Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the 
treatment area, may be treated only following a prophylactic regimen. 
- 
Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction. 
- 
Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash. 
- 
History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin. 
- 
History of bleeding coagulopathies or use of anticoagulants in the last 10 days. 
- 
Any surgery in treated area within 3 months prior to treatment. 
- 
Six months delay is required if other recent treatments like light, CO2 laser or RF were performed on 
the same area. 
- 
Use of Isotretinoin (Accutane®) within 6 months prior to treatment. 
- 
Simultaneously participating in another investigator drug or device study or has completed the 
follow-up phase for the primary endpoint of any previous study less than 1 year prior to the first 
evaluation in this study. 
- 
As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for 
the patient 

 
Treatment with the Evoke System for Facial and Submental Laxity  
Protocol No: DO609886A 
SIRB ID:                     
Rev. Date: 29 Oct. 20 
 
8. Study Procedures 
The Time and Events Schedule is provided in Appendix 1.0.  
8.1 Screening and Baseline (Visit 1)  
Screening visit will be performed in order to determine subject eligibility and to collect all required 
demographic and baseline clinical information. Study procedures and available treatment options, 
including the RF technology will be described in detail to the subject. Subject will be assured that the 
decision regarding participation in the study is strictly voluntary and that they are free to change their 
mind at any stage.  
The subject will review the informed consent form and the study will be explained to the subject 
including all risks, potential benefits, procedures, visit requirements, and other alternative treatment 
options.   If the subject qualifies and wishes to participate, he/she will complete the ICF with a signature 
and date.  The original will be retained with subject’s records and a copy will be provided to the subject. 
Subjects will then be screened for study eligibility according to inclusion and exclusion criteria. 
The following Demographic and Baseline Measurements will be performed: 
- 
Demographic data including gender, age, race, skin type (Fitzpatrick scale). 
- 
ICF - Prior to any study procedures, informed consent will be obtained.  When the subject fully 
understands the possible benefits and risks of the study, the subject will be asked to sign and date 
the informed consent form (ICF).  The subject will be given a copy of the signed ICF. 
- 
Subject ID - subjects will be assigned a study subject ID number.  
- 
Medical History - A medical history will be obtained to determine if the subject meets the study 
criteria, including a list of all prescribed and over the counter medications taken within the 
previous 6 months will be recorded.   
- 
Pregnancy Screen - Subjects who are capable of becoming pregnant will undergo a urine 
pregnancy test. This will be repeated prior to all treatments, and at the end of the study (last FU 
visit, 6-month FU).   
- 
If the Screening and Treatment procedures are not conducted on the same day, the urine 
pregnancy test will be repeated on the first treatment day. 
- 
Photography – Baseline photographs will be obtained using a consistent camera and subject 
placement settings with a digital imaging system. 
- 
3D Photography – Baseline 3D pictures will be obtained using 3D system. PI will ensure the same 
camera is used throughout the study.  
- 
Up to 5 study participants be selected for baseline biopsy  
- 
Scheduling: Subjects will be scheduled to return for the baseline and first treatments visit within 
3 weeks following the screening visit 
8.2 Treatment (visits 1-3) 
The Evoke treatment may occur on the same day of screening and baseline visit (or within 3 weeks 
following screening).  

 
Treatment with the Evoke System for Facial and Submental Laxity  
Protocol No: DO609886A 
SIRB ID:                     
Rev. Date: 29 Oct. 20 
 
Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments (Tx.1, Tx.2 and 
Tx.3). Additional three (3) visits in the clinic will occur to follow-up the skin appearance changes and 
wrinkles reduction at visits 4,5 and 6 (4 weeks (except site #3) 12 weeks and 24 weeks following last 
treatment). 
Treatment area: Treatment area will include face and under chin 
Urine Pregnancy Test will be performed prior to each procedure.  
Treatment procedure: 
• 
Remove any jewellery in the treatment area 
• 
Clean the Evoke Applicator with 70% alcohol.  Detach electrodes from the mask frame (Cheek 
Applicator) using magnetic connection if needed.  
• 
Test the Patient Call Button prior to each session.  This will pause the treatment. 
• 
Long and dense hairs may affect the treatment and should be shaved according to physician’s 
discretion. 
• 
Clean and dry the skin surface prior to applying the Applicators. Ensure there are no creams, 
lotions or sweat residue on the area to be treated.  
• 
Treatment is performed in an upright sitting position. Ensure patient is comfortably seated.  
• 
Make sure that the Applicator for the treatment corresponds to the device interface. 
• 
Apply 2-4mm clear ultrasound gel (not oil) to the treatment area. 
• 
Apply the Evoke Applicator (Chin or Cheeks) on top of the treatment area and adjust according to 
patient comfort. 
• 
For Cheek Applicator: 
o Position the applicator-stabilizer (black metal hoop) on the back of the neck. Adjust the 
applicator according to patient anatomy.  For a wider face, pull the stabilizer all the way 
out. For a narrow face, bring the stabilizer all the way in.  Ensure that patient is seated 
upright when positioning the applicator on the head.  Do not allow the patient to lean 
their head backward as the applicator will shift forward out of position. Patient head must 
remain upright throughout the entire treatment.    
o Secure the Applicator with 2 additional adjustable straps. One strap is positioned on the 
back of the head, and one across the top or the head.  
• 
For Chin Applicator: 
o Place the Applicator on the under-chin area. Ensure that the electrodes are positioned on 
the soft tissue, not on bony areas. The position of the applicator should not be angled or 
tilted.  
o Secure the Applicator with the adjustable strap on the top of the head. Use additional 
silicone strap to secure the Applicator on the chin to prevent it from sliding to the neck.  
o There should be a complete coupling between all Applicator electrodes and the skin 
during the treatment session.  
o Adjust or reposition the Applicator if one or more electrodes do not have complete 
contact with the skin. In the event that the proper coupling between the electrodes and 
the skin cannot be achieved, due to patient anatomy or surface irregularities (such as 

 
Treatment with the Evoke System for Facial and Submental Laxity  
Protocol No: DO609886A 
SIRB ID:                     
Rev. Date: 29 Oct. 20 
 
moles, scars, etc.), disable the specific electrode.  Treatments can still be conducted if one 
or more of the electrodes are disabled. 
• 
Provide patient with Patient Call Button and educate on proper use. 
• 
Start with lower energy levels and gradually increase according to patient’s comfort level. Set 
treatment time to desired treatment duration and press the Start button.  
• 
Treatments can be paused by pressing the Pause button in the upper left corner of the screen.  
• 
In case the Applicator needs to be readjusted or repositioned, pause the treatment, readjust the 
Applicator and restart the treatment. DO NOT readjust the Applicator when treatment is 
activated.  
• 
The procedure should NOT feel hot or intolerable to the patient. If the patient complains of 
discomfort, immediately pause the treatment and inspect the area.  Treatment can be continued 
with one or more of units disabled. Reduce RF power if required. 
• 
Consequent cyclic electrodes activation during the procedure will be reflected on the screen. 
• 
The treatment attendant should not leave the room after starting the treatment as it is important 
for the clinician to ensure that all Applicators reach the desired cut-off temperature and that the 
RF energy is maintained at the cut-off level.  This should take approximately 2-5 minutes.   
• 
During the procedure check Applicators position occasionally, as they can be shifted from the 
original placement.  
 
• 
After the face is treated with Cheek Applicator (for approximately 45 min), if subject’s anatomy 
allows the under-chin area will be treated with Chin Applicator for another 30-45 minutes using 
the same technique as with the Cheek Applicator.  
• 
Typical response to treatment is erythema, slight edema. 
• 
Subject will be asked to rate discomfort during the procedure. Discomfort will be assessed based 
on the Numerical Scale Response (NSR).  The subject will be presented a scale with both words 
and numbers along a horizontal line and asked to make a mark along the scale. The subject will 
be asked to rate discomfort separately for cheeks and chin areas from 0 to 10, with 0 equalling no 
discomfort and 10 equalling the worst possible discomfort. A number is obtained by measuring 
up to the point the subject has indicated. 
• 
After each treatment, observation, assessment and recording of adverse events will be 
conducted. 
 
8.3 Follow up visits (Visits 4, 5 and 6) 
Follow up visits will be conducted at 4 weeks (1-month FU) (except site #3), 12 weeks (3M FU) and 24 
weeks (6M FU) following last treatment. 
 
The 1 month (except site #3), 3 months and 6 months follow up visits will include the following 
assessments: 
• 
Standardized medical photography  
• 
3D Photography 

 
Treatment with the Evoke System for Facial and Submental Laxity  
Protocol No: DO609886A 
SIRB ID:                     
Rev. Date: 29 Oct. 20 
 
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Urine Pregnancy Test (only last 6 months FU visit) 
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Investigator assessment of the skin appearance improvement comparing pre and post 
treatment using 4-point Likert scale 
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Subject’s Improvement and Satisfaction questionnaires 
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Post final treatment biopsy will be performed (up to 5 subjects) 
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AE evaluation recording 
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Concomitant medication recording 
9. Adverse Events Reporting  
9.1 Definitions 
Adverse Event: 
An adverse event (AE) is any adverse change in health or side effect that occurs in a study participant 
during their participation in the study. 
Serious Adverse Event (SAE):  
A serious adverse event (SAE) is any adverse event that: 
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Led to death 
• 
Led to a serious deterioration in the health of the subject that resulted in a life-threatening illness 
or injury 
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Resulted in a permanent impairment of a body structure or a body function 
• 
Required in-subject hospitalization or prolongation of existing hospitalization 
• 
Resulted in medical or surgical intervention to prevent permanent impairment to body structure 
or a body function 
• 
Led to fatal distress, a congenital abnormality, birth defect or death 
 
Unanticipated Adverse Event: 
An unanticipated adverse event is any serious, device-related adverse event, if that event was not 
previously identified in the risk analysis and Informed Consent form in nature, severity, or frequency. 
AE Severity: 
Adverse events are graded according to severity as follows (Table 3): 
Mild 
Sign or symptom, usually transient, requiring no special treatment and 
generally not interfering with usual activities. 
Moderate 
Sign or symptom, which may be ameliorated by simple therapeutic 
measures; yet, may interfere with usual activity. 

 
Treatment with the Evoke System for Facial and Submental Laxity  
Protocol No: DO609886A 
SIRB ID:                     
Rev. Date: 29 Oct. 20 
 
Severe 
Sign or symptom that are intense or debilitating and that interfere with 
usual activities. Recovery is usually aided by therapeutic measures.   
Relationship to Device: 
The relationship of the adverse event to the treatments or procedures is defined as follows (Table 4): 
Most Probably Related: 
Follows a reasonable temporal sequence from study device 
delivery/retrieval and cannot be reasonably explained by known 
characteristics of the subject’s clinical data or the surgical 
procedure applied. 
Possibly Related: 
Follows a reasonable temporal sequence from study device 
delivery/retrieval but could have been produced by the subject’s 
clinical state or by the surgical procedures regardless of the study 
device. 
Probably not Related: 
Temporal association is such that the study device is not likely to 
have had any reasonable association with the observed event. 
Unrelated 
No relationship to study device activation is perceived 
9.2 Anticipated Adverse Events in this Clinical Evaluation 
Possible Evoke adverse effects include but are not limited by:  
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discomfort or pain,  
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excessive skin redness (erythema)  
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swelling (edema),  
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damage to natural skin texture (crust, blister and burn),  
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change of pigmentation (hyper- and hypo-pigmentation), 
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bruising,  
- 
scarring. 
 
9.3 Precautions to Minimize Complications 
A list of warning and precautions is provided in the Operator Manual which is provided to site personnel. 
Additionally, the exclusion criteria listed in this protocol further reduce the abovementioned risks. 
9.4 Investigator Records 
 
The Investigator will report all Adverse Events which occur with each subject throughout the study and 
follow-up period and will record them in the CRF Adverse Events Investigation Form. The Investigator will 
categorize Adverse Events according to: 
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Serious or non-serious 
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Severity  

 
Treatment with the Evoke System for Facial and Submental Laxity  
Protocol No: DO609886A 
SIRB ID:                     
Rev. Date: 29 Oct. 20 
 
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Anticipated or unanticipated  
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Relationship to device use 
9.5 Investigator Reporting of AEs 
The Investigator will report all serious adverse events (SAEs) to InMode Ltd by telephone as soon as 
becoming aware of them. A written follow-up report will be emailed or faxed to InMode Ltd and the 
reviewing IRB within 24 hours and will include the following information: 
1. 
Nature of AE 
2. 
Statement regarding the degree to which it is considered device related, and rationale. 
3. 
Results of any diagnostic tests that were performed. 
4. 
Description of any treatment implemented. 
5. 
Statement of subject’s current clinical status. 
6. 
Investigator’s signature and date. 
Non-serious adverse events that are unanticipated and may be device related will be reported to the 
InMode Ltd by telephone within 24 hours. A written follow-up written report will be emailed or faxed to 
InMode Ltd within 5 working days and will include the following information: 
1. Nature of adverse effect. 
2. Statement as to why it is considered unanticipated. 
3. Statement as to the degree to which it is considered device related, and rationale. 
4. Results of any diagnostic tests that were performed. 
5. Description of any treatment implemented. 
6. Statement of subject’s current clinical status. 
7. Investigator’s signature and date. 
All other Adverse Events will be reported in writing to InMode Ltd in writing within 5 working days of the 
Investigator becoming aware of them.  
The Investigator will continue to clinically monitor the AE, with laboratory tests where appropriate, until it 
is resolved, stabilized or there is a return to baseline. 
10. Regulatory Aspects 
10.1 Institutional Review Board  
The study protocol, informed Consent forms (all versions), and any specific advertising will be submitted 
to and approved by Sterling Institutional Review Board (IRB), at 6300 Powers Ferry Road Suite 600-351, 
Atlanta, GA 30339, Toll-Free: (888) 636-1062, Phone: (770) 690-9491, Fax: (770) 690-9492 before the 
start of the study. The notification of approval will be provided to the sponsor and site. 
10.2 Informed Consent 
An Informed Consent that includes all the relevant elements currently required by FDA or state 
regulations will be provided to each prospective study patient at screening and before enrolling into the 
study. The type and method of study, any potential or possible hazards, and the patient’s right to 

 
Treatment with the Evoke System for Facial and Submental Laxity  
Protocol No: DO609886A 
SIRB ID:                     
Rev. Date: 29 Oct. 20 
 
withdraw from the study at any time will be explained to the patients by the Investigator or designee.  
Once the Investigator is assured that an individual candidate understands the implications of 
participating in this study, the patient will be asked to give Consent by signing and dating in the 
appropriate areas of the Informed Consent form. The Investigator or Designee will also sign and date the 
form in accordance with ICH E6R2 guidance. A copy of the IRB approved ICF will also be provided to the 
subject.  
10.3 Protocol and Informed Consent Changes 
Changes to the protocol or Informed Consent Form will be implemented as amendments to the original 
document and approved by the IRB. The approvals will be processed in accordance with the established 
IRB procedures. Any addenda, amendment or revision that substantially alters the study design or 
increases potential risk to the patient requires the patient’s Consent to continue in the study. 
10.4 Product Supply and Maintenance  
The device will be maintained by the Sponsor, as needed. The device will be used according to the 
instructions of the Sponsor and manufacturer, InMode.  At the end of this study, any materials provided 
specifically for use in this study may be returned to the Sponsor, as described in the Clinical Trial 
Agreement and study budget. 
10.5 Privacy of Personal Data 
The subject's name and personal data will remain confidential and will not be published in any way. All 
reports and communications relating to study subjects will identify the subject only by his/her subject 
number and study 3-letter code. The Study staff will complete subject identification in a confidential 
enrolment log, which will be used for the purposes of traceability and follow-up. This will be treated 
with strict adherence to professional standards of confidentiality and will be filed under adequate 
security and restricted accessibility. 
10.6 Confidentiality Statement 
This document contains confidential information that must not be disclosed to anyone other than the 
Sponsor, the Investigator Team, regulatory authorities, and members of the Research Ethics Committee.   
11. Documentation 
11.1 Case Report Forms (CRFs) 
Paper case report forms will be used in this trial. All protocol-required information collected during the 
study must be entered in the appropriate field of the case report form (CRF). The investigator, or 
designated representative, should complete the appropriate CRF fields as soon as possible after 
information is collected. The information must match the information that exists as source documents in 

 
Treatment with the Evoke System for Facial and Submental Laxity  
Protocol No: DO609886A 
SIRB ID:                     
Rev. Date: 29 Oct. 20 
 
the clinic chart, hospital chart, and/or investigator’s files. An explanation should be given for all missing 
data. 
It is the investigator’s responsibility to assure the accurate completion, review, and approval of all CRFs 
and the timely completion and submission of all adverse event forms. 
11.2 Maintenance and Retention of Records 
Investigators will maintain all study related documentation for a period of five years following: 1) 
marketing authorization for device commercialization, or 2) sponsor’s withdrawal of submission for 
approval, or 3) completion of the study, if the investigational device is already approved for 
commercialization. 
All printouts and records of tests and procedures are to be kept in a secure and safe place throughout 
the study.  Once the study is completed, the records will be kept as required by local regulations, but in 
no case less than the period defined above. 
The Investigator will not relocate or dispose of any study documents before obtaining sponsor’s written 
permission. 
Documentation should be kept so as to make its retrieval easy should an audit take place. 
All study documentation will be kept locked under the Investigator’s responsibility. 
11.3 Reports 
Study reports include a Final Report that will be issued by the Sponsor. Report format will be designed 
by the Sponsor. 
All study reports will be signed by the Principal Investigators approving its contents, analysis, results and 
conclusions.  
AE related reporting requirements are specified above. 
12. Monitoring Plan 
12.1 General Considerations 
Monitoring functions will be performed in compliance with Good Clinical Practices, EN ISO 14155, and as 
outlined in 21CRF§812.43(d) and 21CRF§812.46. InMode Ltd procedures detail monitoring procedures 
and monitor responsibilities.  
The study will be monitored by the sponsor periodically at the site, per Sponsor discretion.  

 
Treatment with the Evoke System for Facial and Submental Laxity  
Protocol No: DO609886A 
SIRB ID:                     
Rev. Date: 29 Oct. 20 
 
12.2 On-Site Visits 
Periodic on-site monitoring visits are intended to assess the Investigator’s adherence to the protocol, 
maintenance of records and reports, and review of source documents for accuracy, completeness, and 
legibility, and monitoring of Adverse Events. 
During periodic visits the monitor is required to: 
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Assess the progress of the study towards meeting study objectives. 
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Identify any concerns that stem from observations of device performance and/or review of the 
subject’s CRF, study management documents, and informed Consent documents.  
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Monitor AE reporting and investigations. 
Reports of on-site visits will be submitted by the monitor and will include, as applicable, resolution of 
concerns, completion of appropriate follow-up activities, completion of assigned tasks, and corrective 
actions. Some ‘visits’ may be performed using a conference call/video conference call and will not be actual 
physical visits. 
12.3 Site Initiation Meeting 
A Site Initiation visit will take place prior to initiation of study procedures.  All study related documents and 
procedures will be explained to all staff involved in the study to ensure understanding of the study 
requirements.  Suitability of potential study subjects will also be evaluated prior to their inclusion. 
12.4 Adverse Event Reporting and Follow-up 
Monitoring of adverse events, their follow up and outcomes will take place at each study visit. 
12.5 Site Closure Visit 
A Site Closure Visit will be conducted to ensure that all relevant documentation is filed and archived under 
the Investigator’s responsibility according to regulations. 
13. Risk/Benefit Analysis  
13.1 Expected Risks: 
As indicated in section 10.2 possible Evoke handpiece adverse effects include but are not limited by:  
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discomfort or pain,  
• 
excessive skin redness (erythema)  
• 
swelling (edema),  
• 
damage to natural skin texture (crust, blister and burn),  
• 
change of pigmentation (hyper- and hypo-pigmentation), 
• 
bruising,  
• 
scarring. 

 
Treatment with the Evoke System for Facial and Submental Laxity  
Protocol No: DO609886A 
SIRB ID:                     
Rev. Date: 29 Oct. 20 
 
These risks are minimal when compared to other methods of skin tightening that are being utilized (such 
us surgical facelift).  
13.2 Expected Benefits:  
The expected benefit of using the Evoke is achieving the desired skin improvement via non invasive 
technique. It is obvious that the low risk profile of the RF utilizing Evoke device greatly benefits the 
individual seeking treatment for skin appearance improvement and wrinkles reduction as it significantly 
minimizes the risks associated with other techniques such as surgery.  
13.3 Conclusion:  
It can therefore be claimed that the expected benefits associated with the use of the Evoke device 
outweigh its risks. 
14. Data analysis  
14.1 Analysis Sets 
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Safety Analysis Set 
The safety analysis set will include all subjects using Embrace procedures at least a single time. 
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Performance Analysis Set 
Performance analysis set will consist of all subjects providing at least one post treatment performance 
measurement. 
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Treatment of Missing Values 
Only observed data will be used; i.e. missing data will not be imputed. 
14.2 Statistical Analysis  
Means, and standard deviations for each characteristic will be calculated.  Paired sample t-test will be 
computed to assess changes in before treatment and follow-up scores. Statistical significance will be 
calculated and two-tail significance level of 0.05 will be used. 
15. Data Management Plan 
Case Report Forms will be retrieved by Monitors after verification and resolution of monitoring queries. 
Documents will be delivered to InMode Ltd onsite data management facility where forms will be logged 
in, and then data will be entered into a prepared Excel file.  
Data will be entered using a double entry method and controlled by periodic and random validation check.