ICYMI: SkinStylus Gains FDA Clearance for Periorbital Wrinkles Across All Fitzpatrick Skin Types

SkinHealth Systems has announced that the US Food and Drug Administration (FDA) has cleared the SkinStylus SteriLock MicroSystem for the improvement of the appearance of periorbital wrinkles in adults aged 22 years and older across all Fitzpatrick skin types (I-VI).¹ 

According to the company, the new indication expands the device’s FDA-cleared uses and positions SkinStylus as the only microneedling device currently cleared for facial acne scars, periorbital wrinkles, and abdominal scars. The latest clearance broadens the clinical applications of the Class II medical device, which uses fine needles to create controlled micro-injuries in the skin to support the skin’s natural renewal process. 

MORE IN AESTHETICS

Expanding a Portfolio of Cleared Indications

Whitney Cypes, chief brand and clinical innovation officer at SkinHealth Systems, described the clearance as an important milestone for both the SkinStylus platform and the company’s broader strategy. “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,” she said in a statement. “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.”¹

The newly cleared indication adds to 2 existing FDA-cleared uses for SkinStylus. In addition to improving the appearance of periorbital wrinkles in Fitzpatrick skin types I through VI, the device is cleared for the improvement of the appearance of facial acne scars in Fitzpatrick skin types I, II, and III, as well as surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years and older.

Clinical Data and Trial Performance

The clearance is supported by clinical data that was recently presented at the 2026 Symposium for Cosmetic Advances and Laser Education (SCALE) Annual Meeting. According to principal investigator Glynis Ablon, MD, FAAD, the findings demonstrated statistically and clinically meaningful improvements in periorbital wrinkles.

“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. 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,” she said.¹

Meeting a Rising Demand for Combination Therapies

The announcement also highlights continued growth in the microneedling market. Reported market data indicates that consumer spending on microneedling procedures in US medical aesthetic practices increased 33% year over year in 2025, reaching approximately $330 million.² According to SkinHealth Systems, the increase reflects growing patient interest in minimally invasive treatments focused on improving overall skin quality.

SkinHealth also emphasized the increasing use of combination treatment protocols involving its flagship HydraFacial platform and microneedling procedures. Approximately 1 in 5 HydraFacial consumers also underwent a microneedling treatment during the previous year. Survey data further suggested strong future interest in combination therapy, with 90% of Hydrafacial consumers reporting they would be interested in pairing microneedling with a Hydrafacial treatment to maximize treatment outcomes. 

With the addition of this new FDA clearance, the company continues to expand the clinical profile of the SkinStylus platform while reinforcing its strategy of supporting aesthetic providers with devices backed by regulatory clearance and clinical validation. SkinStylus has been positioned to integrate into both medical and aesthetic practices across the US, alongside HydraFacial and nano-channeling procedures.

References

1. SkinStylus® Receives New FDA Clearance for the Improvement of Periorbital Wrinkles for All Skin Types. News release. Globe Newswire. Published July 7, 2026. Accessed July 8, 2026. https://www.globenewswire.com/news-release/2026/07/07/3323153/0/en/skinstylus-receives-new-fda-clearance-for-the-improvement-of-periorbital-wrinkles-for-all-skin-types.html?_gl=1*a1kupp*_up*MQ..*_ga*MjMzMjM0MTIxLjE3ODM0MzAyNTQ.*_ga_B6167QB2TF*czE3ODM0MzAyNTQkbzEkZzAkdDE3ODM0MzAyNTQkajYwJGwwJGgxNTM4MTAxMTIz*_ga_ERWPGTJ5X8*czE3ODM0MzAyNTQkbzEkZzAkdDE3ODM0MzAyNTQkajYwJGwwJGgw

2. Guidepoint 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.