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REGULATORY CLEARANCES [ More ]
Venus Versaā¢ 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 for Fitzpatrick skin types I-IV. The AC Dual applicator has CE Mark for the treatment of acne vulgaris. The DiamondPolarā¢ applicator has CE Mark for non-invasive treatment of moderate to severe facial wrinkles and rhytides on females with Fitzpatrick skin types I-IV. The OctiPolarā¢ applicator on the Venus Versaā¢ system has CE Mark for temporary body contouring via skin tightening, circumferential reduction, and cellulite reduction. The NanoFractional RFā¢ (Viva) applicator has CE Mark for dermatological procedures requiring ablation and resurfacing of the skin.
NeoGraftĀ® 2.0 has CE Mark and TGA with indication for use in suction-assisted follicular extraction and re-implantation for males and females.
The ARTAS iXā¢ from Restoration RoboticsĀ® is indicated for harvesting hair follicles from the scalp in men diagnosed with androgenic alopecia (male pattern hair loss) who have black or brown straight hair. The ARTAS iXā¢ from Restoration RoboticsĀ® is intended to assist physicians in identifying and extracting hair follicular units from the scalp during hair transplantation; creating recipient sites; and implanting harvested hair follicles.
Venus Epileveā¢ has CE Mark for hair removal, permanent hair reduction (defined as the long-term stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen), and the treatment of pseudofolliculitis barbae for all Fitzpatrick skin types. Venus Epileveā¢ is also CE-Marked for hirsutism.Ā
Venus Legacyā¢ has CE Mark for the temporary increase of skin tightening, circumferential reduction, cellulite reduction, and wrinkle reduction.
Venus Velocityā¢ has CE Mark for hair removal, permanent hair reduction (defined as the long-term stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen), and the treatment of pseudofolliculitis barbae for all Fitzpatrick skin types.
Venus Vivaā¢ has CE Mark for the use in dermatologic and general surgical procedures requiring ablation and resurfacing of the skin, and the treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I-IV with the DiamondPolarā¢ applicator.
Venus Freeze Plusā¢ has CE Mark for treatment of moderate to severe facial wrinkles and rhytides using the DiamondPolarā¢ applicator, and CE Mark for the treatment of cellulite reduction, increase of skin tightening, and temporary circumferential reduction on the OctiPolarā¢ applicator.
Venus Freezeā¢ has CE Mark for treatment of moderate to severe facial wrinkles and rhytides using the DiamondPolarā¢ applicator, and CE Mark for the treatment of cellulite reduction, increase of skin tightening, and temporary circumferential reduction on the OctiPolarā¢ applicator.
Venus Glowā¢ provides a dermal rejuvenation treatment that works to open up and deep-clean pores. Venus Concept is the exclusive distributor for Venus Glowā¢.
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