safety and efficacy of the btl-785f device for non-invasive reduction of submental fat

Conditions: Skin Laxity

Summary: this study will evaluate the clinical safety and the performance of the btl-785f system equipped with the btl-785-7 applicator for non-invasive reduction of submental fat and skin laxity treatment.


Eligibility criteria:
inclusion criteria: * healthy male or female subjects over 21 years of age seeking treatment for reduction of submental fat * subjects should be able understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the informed consent form * presence of clearly visible excess fat in submentum as deemed appropriate by the investigator * subjects willing and able to abstain from partaking in any facial treatments other than the study procedure during study participation * willingness to comply with study instructions, to return to the clinic for the required visits, and to have photographs of their face taken exclusion criteria: * local bacterial or viral infection in the area to be treated * local acute inflammation in the area to be treated * impaired immune system caused by any immunosuppressive illness, disease or medication * isotretinoin and tretinoin-containing medication use in the past 12 months * skin related autoimmune diseases * radiation therapy and/or chemotherapy * poor healing and unhealed wounds in the treatment area * metal implants * 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)1 * 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 edemas1 * 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 fat reduction, anti-aging or anti-wrinkles 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 at the investigator discretion that may pose risk to the patient or compromise the study