Yes, Skinvive by Juvéderm is FDA approved. The product received 510(k) clearance from the FDA in September 2023, making it the first and currently only hyaluronic acid (HA) filler cleared specifically for improving skin quality and texture in the cheeks and neck through intradermal microdroplet injection.
This is a meaningful regulatory distinction. Skinvive is not approved for volume restoration or facial contouring, which is the traditional domain of dermal fillers. Instead, it targets the superficial dermis to address skin laxity, fine lines, and overall skin quality, positioning it in a category between traditional fillers and skin-tightening devices.