SkinStylus gets FDA clearance for periorbital wrinkles across skin types

SkinHealth Systems Inc. (NASDAQ: SKIN) announced that the U.S. Food and Drug Administration has cleared its SkinStylus microneedling device for the improvement of periorbital wrinkles in adults aged 22 and older across all Fitzpatrick skin types (I–VI).

The SkinStylus SteriLock MicroSystem, classified by the FDA as a Class II medical device, now carries three FDA-cleared indications: improvement in the appearance of periorbital wrinkles, including crow's feet; improvement in the appearance of facial acne scars in Fitzpatrick skin types I, II, and III; and improvement in the appearance of surgical or traumatic hypertrophic scars on the abdomen.

Whitney Cypes, Chief Brand and Clinical Innovation Officer at SkinHealth Systems, said the clearance "marks an important milestone for SkinStylus" and that expanding FDA-cleared indications "better positions us to compete in the microneedling category."

Clinical data supporting the new periorbital wrinkle indication was presented at the 2026 SCALE Annual Meeting. Dr. Glynis Ablon, a principal investigator in the clinical study, said the device "demonstrated statistically and clinically meaningful improvements in periorbital wrinkles across all Fitzpatrick skin types."

According to data from Guidepoint Qsight, consumer spending on microneedling in U.S. medical aesthetic practices grew 33% year-over-year in 2025, reaching approximately $330 million. The data is based on point-of-sale transactions from more than 3,400 U.S. aesthetics practice locations.

SkinHealth Systems also noted that approximately one in five Hydrafacial treatment consumers received a microneedling treatment in the past year, citing the same Qsight data. A separate January 2026 survey of 763 respondents by NewBeauty Beauty Engine found that 90% of Hydrafacial consumers expressed interest in combining microneedling with a Hydrafacial treatment.

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