SkinHealth Systems Inc. (SKIN), 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 latest clearance expands SkinStylus clinically supported indications, making it the only microneedling device cleared for facial acne scars, periorbital wrinkles, and abdominal scars. The company emphasized that the decision reinforces its commitment to science-backed innovation within professional aesthetics.
Whitney Cypes, Chief Brand and Clinical Innovation Officer of SkinHealth Systems, called the clearance "an important milestone", noting that expanding FDA-cleared indications strengthens SkinStylus competitive position in the fast-growing microneedling category.
Microneedling, a minimally invasive procedure using fine needles to create controlled micro-injuries in the skin, supports natural renewal processes to improve texture and firmness. Demand for such treatments continues to rise, with U.S. consumer spending on microneedling growing 33% year-over-year to approximately $330 million in 2025.
The FDA categorized SkinStylus as a Class II medical device. Its cleared indications now include improvement in periorbital wrinkles (including crow's feet), facial acne scars in certain skin types, and hypertrophic abdominal scars.
SKIN has traded between $0.55 and $2.69 over the past year. The stock closed Tuesday's trading at $1.11, up 47.04%. During after-hours trading session, the stock is at $1.02, down 8.11%.
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