![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Venus Concept’s AI.ME Cleared for Fractional Skin Resurfacing
Venus Concept’s AI.ME Cleared for Fractional Skin Resurfacing
The FDA has granted 510(k) clearance to Venus Concept’s AI.ME next generation robotic technology for fractional skin resurfacing to reduce the appearance of wrinkles and acne scars.
Fractional skin resurfacing is a laser treatment that stimulates the skin's renewal process. The robotic AI.ME system combines a visualization system, machine vision and artificial intelligence to precisely target the dermis portion of the skin.
AI.ME also includes micro-coring hollow punches to remove up to 10 percent of skin in the intended treatment area.
The company plans on launching the AI.ME system in 2023.
Upcoming Events
-
21Oct