Evaluation of Safety and Efficacy of the BTL-785F Device for Non-invasive Facial Remodeling

Exclusion Criteria

• •Local bacterial or viral infection in the area to be treated
• •Local acute inflammation in the area to be treated
• •Isotretinoin and tretinoin-containing medication use in the past 12 months
• •Impaired immune system caused by any immunosuppressive illness, disease or medication
• •Skin related autoimmune diseases
• •Radiation therapy and/or chemotherapy
• •Poor healing and unhealed wounds in the treatment area
• •Metal implants1
• •Permanent implant in the treated area
• •Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body
• •Facial dermabrasion, facial resurfacing, or deep chemical peeling in the treatment area 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 skin disorders, keloids, abnormal wound healing and dry or fragile skin
• •History of any type of cancer
• •Active collagen diseases
• •Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis)
• •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 and rosacea
• •Any surgical procedure in the treatment area within the last three months or before complete healing
• •Poorly controlled endocrine disorders, such as diabetes
• •Acute neuralgia and neuropathy
• •Kidney or liver failure
• •Nerve insensitivity (sensitivity disorders) to heat in the treatment area
• •Varicose veins, pronounced edemas
• •Prior use of dermal fillers, botulinum toxin, lasers, etc. therapies in the treated area that can influence the study results at the investigator discretion
• •Unwillingness/inability to not change their usual cosmetics and especially not to use anti-aging or facelift products in the treated area during the duration of the study including the follow-up period
• •Electroanalgesia without exact diagnosis of pain etiology
• •Neurological disorders (such as multiple cerebrospinal sclerosis, epilepsy)
• •Blood vessels and lymphatic vessels inflammation
• •Any other disease or condition (e.g. eye disease) at the investigator discretion that may pose risk to the patient or compromise the study