SkinHealth's SkinStylus Gets FDA Clearance for Periorbital Wrinkles

Regulation
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SkinHealth Systems Inc., the company behind the Hydrafacial brand, announced that the U.S. FDA has cleared its SkinStylus microneedling device for the improvement of periorbital wrinkles in adults aged 22 and older, across all Fitzpatrick skin types. This clearance expands SkinStylus's indications, making it the only microneedling device cleared for facial acne scars, periorbital wrinkles, and abdominal scars. The FDA categorized SkinStylus as a Class II medical device, with cleared indications now including periorbital wrinkles such as crow's feet, facial acne scars in certain skin types, and hypertrophic abdominal scars. Whitney Cypes, Chief Brand and Clinical Innovation Officer, called the clearance an important milestone that strengthens the device's competitive position in the fast-growing microneedling category, where U.S. consumer spending grew 33% year-over-year to approximately $330 million in 2025. The stock closed Tuesday's trading at $1.11, up 47.04%, and was at $1.02 in after-hours trading, down 8.11%.

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