The FDA has cleared the SkinStylus microneedling device for the improvement of periorbital wrinkles in adults aged 22 years and older across all Fitzpatrick skin types, expanding its list of cleared indications.
SkinHealth Systems Inc announced that the US Food and Drug Administration has cleared its SkinStylus microneedling device for the improvement of the appearance of periorbital wrinkles in adults aged 22 years and older across Fitzpatrick skin types I through VI. According to the company, the new clearance expands the device’s FDA-cleared indications and makes the SkinStylus SteriLock MicroSystem the only microneedling device with indications for facial acne scars, periorbital wrinkles, and abdominal scars.
Expanded FDA Clearance
The new indication covers improvement in the appearance of periorbital wrinkles, including crow’s feet, in adults aged 22 years and older across all Fitzpatrick skin types. The SkinStylus SteriLock MicroSystem is categorized by the FDA as a Class II medical device.
In addition to the new indication, the device is FDA-cleared for improvement in the appearance of facial acne scars in Fitzpatrick skin types I, II, and III, and for improvement in the appearance of surgical or traumatic hypertrophic scars on the abdomen.
“Achieving FDA clearance for the improvement of periorbital wrinkles marks an important milestone for SkinStylus and for SkinHealth Systems,” said Pedro Malha, Chief Executive Officer of SkinHealth Systems. “As microneedling continues to grow rapidly within medical aesthetics, we are refocusing on SkinStylus because we believe in its clinical strength and 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.”
Clinical Study Findings
According to the company, the clinical data supporting the new indication has been accepted for presentation at the 2026 SCALE Annual Meeting.
“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 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.”
Microneedling Market Growth
The company cited Guidepoint Qsight data showing that consumer spending on microneedling in US medical aesthetic practices increased 33% year over year in 2025 to approximately $330 million.
SkinHealth Systems also reported that approximately one in five Hydrafacial treatment consumers received a microneedling treatment during the past year. According to a January 2026 NewBeauty Beauty Engine Survey cited by the company, 90% of Hydrafacial treatment consumers said they are interested in combining microneedling with a Hydrafacial treatment in the future.
Photo: SkinHealth Systems Inc
