Skin contouring system, radio-frequency

Intended purpose

An assembly of devices that uses radio-frequency (RF) electromagnetic (EM) energy [typically in the bands below 10 megahertz (MHz)] to generate heat deep within body tissues to temporarily minimize the manifestation of cellulite, loose or wrinkled skin through a process of fat removal, skin regrowth and tightening, and the temporary relief of pain. It typically consists of monopolar and/or bipolar applicators attached to an energy-producing generator, typically with a cooling module. The tissues are warmed in a controlled manner to produce the desired therapeutic effect whilst cryogen cooling of the epidermis may be employed. This device is not used for the treatment of malignancies.