SkinStylus Receives New FDA Clearance for the Improvement of Periorbital Wrinkles for All Skin Types
SkinHealth Systems Inc., home to flagship brand Hydrafacial, announced that the U.S. Food and Drug Administration (FDA) has cleared the SkinStylus microneedling device for the improvement of the appearance of periorbital wrinkles in adults aged 22 years and older for all Fitzpatrick skin types.
This latest clearance expands SkinStylus’ clinically supported indications and reinforces SkinHealth System’s commitment to science-backed innovation within its professional ecosystem.
“Achieving FDA clearance for the improvement of periorbital wrinkles marks an important milestone for SkinStylus and for SkinHealth Systems,” said Whitney Cypes, Chief Brand and Clinical Innovation Officer of SkinHealth Systems. “As microneedling continues to grow rapidly within medical aesthetics, we are building on SkinStylus’s clinical strength because we believe in its long-term role in our ecosystem. 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 that delivers meaningful, visible results for providers and consumers.”
Fine lines and wrinkles remain among the most common aesthetic concerns worldwide. Microneedling is a minimally invasive procedure that uses fine needles to create controlled micro-injuries in the skin, which helps support the skin’s natural renewal process to improve the appearance of skin texture and promote smoother, firmer, more youthful-looking skin.
Demand for microneedling continues to accelerate. In 2025, consumer spend on microneedling in U.S. medical aesthetic practices grew 33% year-over-year, reaching approximately $330 million.1 The strong growth underscores increasing consumer preference for clinically driven, skin-quality treatments.
SkinStylus SteriLock MicroSystem Now the Only Microneedling Device with Indications for Facial Acne Scars, Periorbital Wrinkles, and Abdominal Scars
Categorized by the FDA as a Class II Medical Device, the SkinStylus SteriLock MicroSystem is FDA-cleared for the following indications in adults aged 22 years and older:
- Improvement in the appearance of periorbital wrinkles in Fitzpatrick skin types I–VI, inclusive of the delicate skin around the eyes 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
“Based on my experience as a principal investigator in the clinical study, SkinStylus demonstrated statistically and clinically meaningful improvements in periorbital wrinkles across all Fitzpatrick skin types, which is a notable advancement in microneedling technology,” said Dr. Glynis Ablon, MD, FAAD. “The device’s multiple FDA-cleared indications further support its versatility in clinical practice. In my experience, patients felt it was a more comfortable procedure compared to other microneedling systems, and I found it much easier to handle as a user, contributing to an improved overall treatment.”
The clinical data supporting the new indication was recently presented at the 2026 SCALE (Symposium for Cosmetic Advances and Laser Education) Annual Meeting, further reinforcing SkinStylus’ commitment to clinically validated innovation and ongoing education within the aesthetic dermatology community.
Hydrafacial treatments have become one of the most popular complementary procedures paired with microneedling and nano-channeling treatments. Approximately one in five Hydrafacial treatment aesthetic consumers also received a microneedling treatment last year, reflecting the growing consumer shift toward combination protocols designed to enhance efficacy and optimize results.1 Interest in this pairing appears to be even stronger looking ahead, with 90 percent of Hydrafacial treatment consumers reporting they are interested in combining microneedling with a Hydrafacial treatment in the future to maximize outcomes.2
SkinStylus integrates seamlessly into medical and aesthetic practices and microneedling and nano-channeling treatments are available at providers across the United States. Learn more at SkinStylus.com.
1Guidepoint Qsight – Sales Measurement from Full Year 2025. Qsight Sales Measurement data is based on point-of-sale transactions from 3,400+ US Aesthetics practice locations.
2NewBeauty Beauty Engine Survey. January 2026. N=763.
About SkinHealth Systems
SkinHealth Systems (NASDAQ: SKIN) is a global medical aesthetics company delivering an integrated ecosystem of clinically proven solutions designed to help consumers achieve superior skin health and support the success of providers. Anchored by Hydrafacial™, a leading and widely requested professional skincare treatment, and supported by complementary offerings including SkinStylus™ microneedling and HydraScalp™ with Keravive™, SkinHealth Systems combines advanced device technology, proprietary consumables, and clinical validation to deliver trusted treatment experiences through an omnichannel network of providers worldwide. Learn more at skinhealthsystems.com or follow us on LinkedIn. Local providers can be found at hydrafacial.com/find-a-hydrafacialist.
