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