Safety and Effectiveness Evaluation of the Device in Achieving Submental Lift

This is an open-label, single-center, single-treatment prospective evaluation of the ThermiRF
device in the treatment of submental skin laxity. The purpose of this prospective study is to
determine the effectiveness and safety of the ThermiRF device in achieving overall submental
lift.

In this study, "Lift" is defined as a ≥ 20 mm2 lift of the submental area after the ThermiRF
treatment.

A total of 70 male and female healthy volunteers between the age of 35 and 65 will be
considered for this study. Subjects who sign the informed consent form and meet all entry
criteria will be enrolled in this study and will be assigned a unique number/code to preserve
confidentiality.

A total of six study visits are planned as described below:

- Visit 1: Screening visit - (Day 1)

- Visit 2: Single Treatment visit

- Visit 3: Day 30 safety assessment (± 7 to 14 days)

- Visit 4: Day 60 safety and Image capture for validation exercise (± 7 to 14 days)

- Visit 5: Day 90 safety and effectiveness follow-up visit (± 7 to 14 days)

- Visit 6: Day 180 safety and effectiveness follow-up visit - (± 7 to 14 days)

Photo images (2D and 3D) will be collected at Visits 1, Visit 4 (on first 30 subjects only),
and at Visits 5 and 6 using a standard camera (2D) and the Vectra system (3D). The purpose of
the photos are to quantitatively and qualitative evaluate treatment effectiveness using
objective and subjective assessments to measure physical changes to the skin's microstructure
and aesthetic skin features over time.

A skin elasticity assessment using the Cutomer will be collected at Visits 1 (screening), 5
(Day 90) and 6 (Day 180) to assess if any biomechanical changes of the skin occurred as a
result of the ThermiRF treatment.

Safety assessments will be collected using the Numerical Rating Scale (NRS) a 10-point scale,
and adverse events reports (observed or reported).

The overall study duration is approximately 12 months (i.e., 5-6 month recruitment period and
6 month study visits).

Inclusion Criteria:

- Male or female between the age of 35 and 65 inclusive;

- Mild to Moderate Skin Laxity Severity on the submental area defined as: "normal"
muscle, "mild to moderate" skin laxity and "mild to moderate" fat;

- Desire to improve jawline definitions and/or submental skin lift

- Body mass index (BMI) ≤30;

- Females of childbearing potential who are sexually active must be willing to use an
approved method of birth control during study participation.

- Cooperative, reliable, and able to read and comprehend English;

- Able to read, understand, sign and date the informed consent document (English only);

- Able and willing to comply with the schedule visit(s) and study requirements.

Exclusion Criteria:

- Excessive subcutaneous fat on the submental area

- Use within 24 hours preceding surgery of ibuprofen, acetaminophen, any other
analgesics, anti-inflammatory products, or any products including herbals and
supplements that could interfere with the clinical assessments of this study (other
than drugs used for anesthesia);

- History of cosmetic treatments on the face and neck including but not limited to:
facial skin tightening procedures within the past year, injectable fillers of any
type, Botox on the lower face, ablative resurfacing laser treatment, none ablative,
rejuvenative laser or light treatment within the past six months, deep facial peels,
dermabrasion, face lift, neck lift, blepharoplasty or brow lift, contour threads or
other.

- History or current injury to the Head and Neck.

- Severe solar elastosis

- Clinically significant facial wounds, lesions or acute infections including cystic
acne, dermatitis, lupus or other immunodeficiency affecting the dermis

- Presence of metal stents or facial implants

- Pregnant or planning pregnancy prior to the end of study participation

- Current or past history of smoking

- History or current diagnosis of cancer of any type

- History of uncontrolled cardiovascular disease(i.e. myocardial infarction,
hypertension, hypercholesterolemia, peripheral vascular disease, other)

- Known hypersensitivity to local anesthetic medications

- History, or current bleeding disorders (i.e. hemophilia or von Willebrand disease), or
anticipated treatment with prescription anticoagulants

- Possesses a surgically implanted electronic device (i.e. pacemaker)

- History of AIDs/HIV

- Serious mental health illness such as dementia or schizophrenia; psychiatric
hospitalization in the past two years

- Developmental disability or cognitive impairment that would preclude adequate
comprehension of the informed consent form and/or ability to follow study subject
requirement and/or record the necessary study measurements

- A family member of the investigator or an employee of the investigator.

- Participation in any other investigational study within 30 days prior to consent;