RF Microneedling With Multi-Depth Targeting Per Insertion for The Treatment of Cellulite

Inclusion Criteria:

• Female subjects aged 18-65 (inclusive)

• BMI interval: 18.5 ≤ BMI ≤ 30 (normal to overweight, but not obese).

• Subject having cellulite grade 1-4 as graded using the Clinician ReportedPhotonumeric Cellulite Severity Scale (CR-PCSS)7.

• The patients should understand the information provided about the treatment,possible benefits and side effects, and sign the Informed Consent Form, (includingthe permission to use photography).

• 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 aesthetictreatment methods (i.e liposuction, any cellulite/circumference reduction treatmentsusing medical devices, etc.) in the treatment area for the last 6 months and duringthe entire study period.

• Females of Childbearing potential must be using an approved method of birth control.Subjects who are capable of becoming pregnant will undergo a urine pregnancy test.

Exclusion Criteria:

• Pacemaker or internal defibrillator, or any other active electrical implant anywherein the body.

• Superficial permanent implant in the treated area such as metal plates and screws,metal piercing, silicone implants or an injected chemical substance.

• Known sensitivity/allergy to Lidocaine

• Current or history of skin cancer (remission of 5 years), or current condition ofany other type of cancer, or pre-malignant moles.

• Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolledhypertension, and liver or kidney diseases.

• Pregnancy and nursing or lactating.

• History of bleeding coagulopathies or use of anticoagulants.

• Chronic or current use of NSAIDs or other anti-inflammatory therapies (e.g.,Ibuprofen, etc.)

• Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or useof immunosuppressive medications.

• Any uncontrolled medical condition (i.e., endocrine disorders, diabetes, thyroiddisfunction or hormonal virilization) that in the opinion of the investigator, thesubject's safety may be compromised.

• Any active condition in the treatment area, such as sores, psoriasis, eczema, andrash.

• History of skin disorders, keloids, abnormal wound healing, as well as very dry andfragile skin.

• Use of Isotretinoin (Accutane®) within 6 months prior to treatment.

• Any surgery or treatment such as laser or chemicals in treated area within 3-6months prior to treatment or before complete healing.

• Any medical condition that in the opinion of the investigator, such condition wouldcompromise the safety of the subject or quality of the study data.

• Current, or past participation in a clinical trial within the past 30 days.