ac26cdfa-ac7f-4ad9-9771-b97f14e5c276UpdatePublished22025-06-302023-06-08In Commercial Distribution00810060830833PrimaryGS1Venus Legacy (120V)LE120004117333774Venus Concept Inc.1falsefalsefalsefalsefalsefalsefalsetruetruefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK14355400045219Radio-frequency skin/body contouring systemAn assembly of devices that uses radio-frequency (RF) electromagnetic (EM) energy [typically in the bands below 10 megahertz (MHz)] to generate heat deep within subcutaneous tissues to temporarily minimize the manifestation of cellulite and loose or wrinkled skin through a process of skin regrowth and tightening and local fat cell alteration/destruction. It typically consists of monopolar and/or bipolar applicators attached to an energy-producing generator, typically with a cooling module. The tissues are warmed to produce the desired therapeutic effect; simultaneous cryogen cooling of the epidermis may be employed. This device is not used for the treatment of malignancies.falseActivePBXMassager, Vacuum, Radio Frequency Induced Heatfalsefalse