Regulatory Clearances

Venus Versa™ has CE Mark as a multi-application device intended to be used in aesthetic and cosmetic procedures. The SR515 and SR580 applicators have CE Mark for the treatment of benign pigmented epidermal and cutaneous lesions and treatment of benign cutaneous vascular lesions. The HR650/HR650XL and HR690/HR690XL applicators have CE Mark for the removal of unwanted hair and to effect stable long-term or permanent hair reduction. The AC Dual applicator has CE Mark for the treatment of acne vulgaris. The DiamondPolar™ applicator has CE Mark for non-invasive treatment of moderate to severe facial wrinkles and rhytides. The OctiPolar™ applicators on the Venus Versa™ system has CE Mark for temporary body contouring via skin tightening, circumferential reduction, and cellulite reduction. The NanoFractional RF™ (Viva) applicator has CE Mark for dermatological procedures requiring ablation and resurfacing of the skin.

Venus Legacy™ has CE Mark for the increase of skin tightening, temporary circumferential reduction, cellulite reduction, and wrinkle reduction.

Venus Viva™ has CE Mark for the use in dermatological procedures requiring ablation and resurfacing of the skin (NanoFractional RF™ applicator), and the treatment of moderate to severe facial wrinkles and rhytides (DiamondPolar™ applicator).