SkinHealth Systems has received FDA clearance for its SkinStylus SteriLock MicroSystem for improving the appearance of periorbital wrinkles in adults aged 22 and older across all Fitzpatrick skin types.
The clearance expands SkinStylus’ indications, making it the only microneedling device with FDA-cleared uses for periorbital wrinkles, facial acne scars, and abdominal scars. The device is designed to create controlled micro-injuries that support skin renewal and improve texture and firmness.
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The new indication is supported by clinical data showing improvements in periorbital wrinkles across all Fitzpatrick skin types.
Chief Brand and Clinical Innovation Officer Whitney Cypes said:
“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.”
The company said the clearance strengthens SkinStylus’ role within SkinHealth Systems’ professional aesthetics portfolio, alongside growing demand for combination treatments such as microneedling paired with Hydrafacial procedures.
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