SkinStylus receives US FDA clearance for periorbital wrinkle treatment

SkinHealth Systems has received US FDA clearance for its SkinStylus microneedling device targeting periorbital wrinkles. The decision makes the SkinStylus SteriLock MicroSystem the only microneedling device with indications for facial acne scarring, periorbital wrinkles, and abdominal scarring.

The FDA’s clearance comes as the microneedling space continues to gain traction, hitting 33% year-over-year growth, and amassing approximately US$330 million in consumer spending in the US in 2025, according to SkinHealth Systems. The clearance applies to adults aged 22 years and older, and across all Fitzpatrick skin types.

“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,” says Whitney Cypes, chief brand and clinical innovation officer at SkinHealth Systems.

“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.”

Addressing beauty concerns 

According to SkinHealth Systems, fine lines and wrinkles are some of the most widespread beauty concerns globally and support a continuously growing segment within the beauty industry.

“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,” the company explains.

The continued growth of the segment indicates that consumers are investing in clinically driven, skin-quality treatments.

SkinStylus applications

SkinStylus received FDA clearance for treating periorbital wrinkles.

The FDA has categorized SkinStylus SteriLock MicroSystem as a Class II Medical Device, clearing it for use across a number of applications.

The system can be used for improvement in the appearance of periorbital wrinkles in Fitzpatrick skin types I–VI, including the skin around the eyes, and for crow’s feet. It also supports applications in improving the appearance of facial acne scars in Fitzpatrick skin types I–III and the appearance of surgical or traumatic hypertrophic scars on the abdomen.

“SkinStylus demonstrated statistically and clinically meaningful improvements in periorbital wrinkles across all Fitzpatrick skin types, which is a notable advancement in microneedling technology,” says Dr. Glynis Ablon, MD, FAAD, who was principal investigator in a SkinStylus clinical study.

She states that the device’s multiple FDA-cleared indications bolster its versatility and applicability 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 says.

Combined treatment approaches

The device is now cleared for facial acne scars, periorbital wrinkles, and abdominal scars.

The growth of microneedling is happening in tandem with the demand for hydrafacial treatments. The resurfacing treatments have become a popular complementary procedure paired with microneedling and nano-channeling treatments.

SkinHealth Systems outlines that approximately one in five consumers who received a hydrafacial treatment also received a microneedling treatment last year. This reflects the growing consumer interest in combination protocols designed to enhance efficacy and optimize results.

Boston Consulting Group and Women’s Wear Daily outlined this combination treatment approach earlier this year. They dubbed the demographic of consumers who personalize their beauty journey through layering treatments the “optimizers.”

Based on a survey of 5,000 US beauty consumers, the report revealed how brands and retailers can keep up with evolving demands by considering the “optimizer.” The report states that if the “optimizer” consumer segment doubles, it may generate over US$30 billion in revenue across the broader personal care industry.

SkinHealth Systems states that interest in the pairing of hydrafacial and microneedling as complementary treatments may be more widespread in the future. It reports 90% of Hydrafacial treatment consumers say they are interested in combining the treatments to optimize results.