Radiofrequency and Ultrasound for Improvement of Skin Laxity and Wrinkles: Efficacy and Safety Evaluation

Inclusion Criteria: * Healthy male or female subjects over 21 years of age seeking treatment and reduction of facial wrinkles and facial skin laxity * Subjects should be able to understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form * Presence of clearly visible wrinkles in the treated area when the face is relaxed 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: * Bacterial or viral infection, acute inflammations * Impaired immune system * Isotretinoin 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 6 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 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 * Sensitivity disorders 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 ani-aging or anti-wrinkles products in the treated area during the duration of the study including the follow-up period * Any other disease or condition (e.g. eye disease) at the investigator discretion that may pose risk to the patient or compromise the study