FDA Approves SkinStylus: A Revolutionary Microneedling Device for Under-Eye Wrinkles
A significant advancement in aesthetic medicine was unveiled this week. SkinHealth Systems (NASDAQ: SKIN) announced that the U.S. Food and Drug Administration has granted extended clearance for its SkinStylus SteriLock MicroSystem. This makes it the world’s first and only microneedling device specifically cleared to enhance the appearance of under-eye wrinkles, including crow’s feet, for adults aged 22 and older across all Fitzpatrick skin types.
The fresh FDA clearance broadens the device’s already-approved indications, which previously included facial acne scars and hypertrophic abdominal scars. As a Class II medical device, the SkinStylus deploys fine needles to generate controlled micro-injuries in the skin. This stimulates the body’s natural renewal process, enhancing texture and firmness around the delicate periorbital area.
The popularity of microneedling treatments has skyrocketed, with Americans spending approximately $330 million on microneedling in 2025 alone. This represents a staggering 33% increase year-over-year, according to Guidepoint Qsight data cited by SkinHealth Systems. The clinical data supporting this new under-eye indication was also recently presented at the 2026 SCALE (Symposium for Cosmetic Advances and Laser Education) Annual Meeting, further solidifying the device’s scientific credibility.
“The device’s multiple FDA-cleared indications further support its versatility in clinical practice,” said Dr. Glynis Ablon, MD, FAAD, a principal investigator in the clinical study.
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