Safety and Efficacy of the BTL-FR2000 Device for the Treatment of Facial Wrinkles

Inclusion Criteria:

• Age ≥ 22 years

• Voluntarily signed informed consent form

Exclusion Criteria:

• Bacterial or viral infection, acute inflammations

• Impaired immune system

• Isotretinoin in the past 12 months

• Skin related autoimmune diseases

• Radiation therapy and chemotherapy

• Poor healing and unhealed wounds in the treatment area

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

• Metal implants

• Permanent implant in the treated area

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

• Facial dermabrasion, facial resurfacing, or deep chemical peeling in the treatmentarea within 3 months prior to the treatment

• Current or history of skin cancer, or current condition of any other type of cancer,or pre-malignant moles

• History of any kind of cancer

• Active collagen diseases

• Cardiovascular diseases (such as cardiac and vascular diseases, peripheral arterialdisease, thrombophlebitis, thrombosis, etc.)

• Pregnancy/nursing or IVF procedure

• History of bleeding coagulopathies, use of anticoagulants

• Any active condition in the treatment area, such as sores, psoriasis, eczema, rash androsacea

• Any surgical procedure in the treatment area within the last three months or beforecomplete healing

• Poorly controlled endocrine disorders, such as diabetes

• Children under age of 21

• Excessively tanned skin from sun, tanning beds or tanning creams within the last twoweeks

• Patients with allergy to anesthetics should not be treated under anesthesia

• Botox®/collagen/fat injections or other injected bio-material in the treated areawithin three months prior to treatment

• Use of non-steroidal anti-inflammatory drugs one week before and after each treatmentsession

• Treating over tattoo or permanent makeup