USFDAJul 7, 2026, 08:07 AM
SkinHealth Systems' SkinStylus FDA-Cleared for Periorbital Wrinkles
AI Summary
SkinHealth Systems Inc. announced that its SkinStylus microneedling device has received U.S. FDA clearance for the improvement of the appearance of periorbital wrinkles in adults aged 22 and older across all Fitzpatrick skin types. This expands the device's clinically supported indications, which now include facial acne scars and abdominal scars. The company highlighted the rapid growth in the microneedling market, with consumer spend reaching $330 million in 2025, and strong interest in combining microneedling with Hydrafacial treatments.
Key Highlights
- SkinStylus microneedling device received FDA clearance for improving periorbital wrinkles in adults aged 22+ across all Fitzpatrick skin types.
- The device is now cleared for facial acne scars, periorbital wrinkles, and abdominal scars.
- U.S. consumer spend on microneedling in medical aesthetic practices grew 33% year-over-year in 2025, reaching approximately $330 million.
- Approximately one in five Hydrafacial treatment consumers also received a microneedling treatment last year.
- 90% of Hydrafacial treatment consumers are interested in combining microneedling with a Hydrafacial treatment in the future.
- SkinStylus SteriLock MicroSystem is categorized by the FDA as a Class II Medical Device.
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