SkinHealth Systems Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the SkinStylus microneedling device for the improvement of the appearance of periorbital wrinkles in adults aged 22 years and older for all Fitzpatrick skin types. This latest clearance expands SkinStylus’ clinically supported indications and reinforces SkinHealth System’s commitment to 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.”
Categorized by the FDA as a Class II Medical Device, the SkinStylus SteriLock MicroSystem is FDA-cleared for the following indications in adults aged 22 years and older:
- 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.