SkinHealth Systems Inc. said the U.S. Food and Drug Administration has cleared its SkinStylus microneedling device for the improvement of the appearance of periorbital wrinkles in adults aged 22 years and older across all Fitzpatrick skin types.
The company said the clearance adds to SkinStylus’ clinically supported indications. It also said the move reinforces SkinHealth Systems’ focus on science-backed innovation within its professional ecosystem.
"Achieving FDA clearance for the improvement of periorbital wrinkles marks an important milestone for SkinStylus and for SkinHealth Systems", says Whitney Cypes, chief brand and clinical innovation officer of SkinHealth Systems. "As microneedling continues to grow rapidly within medical aesthetics, we are building on SkinStylus’s clinical strength because we believe in its long-term role in our ecosystem. Expanding our FDA-cleared indications better positions us to compete in the microneedling category and reinforces our strategy to build a differentiated, science-backed platform that delivers meaningful, visible results for providers and consumers."
The FDA categorizes the SkinStylus SteriLock MicroSystem as a Class II Medical Device. According to the company, the device is FDA-cleared for adults aged 22 years and older for:
- improvement in the appearance of periorbital wrinkles in Fitzpatrick skin types I–VI, inclusive of the delicate skin around the eyes including crow’s feet
- improvement in the appearance of facial acne scars in Fitzpatrick skin types I, II, and III
- improvement in the appearance of surgical or traumatic hypertrophic scars on the abdomen
The newly announced clearance specifically covers periorbital wrinkles, including the delicate skin around the eyes and crow’s feet, in Fitzpatrick skin types I–VI.
