FDA clears SkinStylus microneedling device for periorbital wrinkles

The FDA has cleared the SkinStylus SteriLock MicroSystem for treating periorbital wrinkles in adults aged 22 and older, making it the only microneedling device on the market cleared for facial acne scars, abdominal scars, and now crow's feet. This update expands your clinical utility because the periorbital clearance covers all Fitzpatrick skin types (I through VI), whereas the device's clearance for facial acne scars remains limited to types I through III.

For your practice, this means a broader patient base can safely receive targeted microneedling around the eyes without the hyperpigmentation concerns often tied to energy-based devices on darker skin. Clinical data presented at the 2026 SCALE meeting showed statistically significant wrinkle improvement, which helps back up the treatment's efficacy when discussing options with patients. Economically, this clearance aligns with strong consumer demand. Market data from 2025 shows the U.S. microneedling market reached 330 million dollars after 33 percent year-over-year growth, with substantial overlap in patients seeking HydraFacials. If you already offer HydraFacials, this device serves as a highly marketable cross-sell, as internal data suggests nearly all HydraFacial patients are interested in pairing the two therapies.

Source: GlobeNewswire, https://www.globenewswire.com/news-release/2026/07/07/3335894/0/en/SkinStylus-SteriLock-MicroSystem-Now-the-Only-Microneedling-Device-with-Indications-for-Facial-Acne-Scars-Periorbital-Wrinkles-and-Abdominal-Scars.html