SkinStylus® Receives New FDA Clearance for the Improvement of Periorbital Wrinkles for All Skin Types
SkinStylus SteriLock MicroSystem Now the Only Microneedling Device with Indications for Facial Acne Scars, Periorbital Wrinkles, and Abdominal Scars
Hydrafacial Treatment Pairing Continues to Drive Adoption of Microneedling Protocols
LONG BEACH, Calif., July 07, 2026 (GLOBE NEWSWIRE) -- SkinHealth Systems Inc. (NASDAQ:SKIN), home to flagship brand Hydrafacial, today 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.
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.
Forward-Looking Statements
Certain statements made in this release are "forward looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding SkinHealth Systems Inc.’s strategy, plans, objectives, initiatives and financial outlook. When used in this press release, the words "estimates," "projected," "expects," "anticipates," "forecasts," "plans," "intends," "believes," "seeks," "may," "will," "should," "future," "propose" and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements.
These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside SkinHealth Systems Inc.’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. As such, readers are cautioned not to place undue reliance on any forward-looking statements.
Important factors that may affect actual results or outcomes include, among others: SkinHealth Systems Inc.’s ability to manage growth; SkinHealth Systems Inc.’s ability to execute its business plan; the effects of obtaining and/or maintaining indications related to SkinStylus; the continued growth of the microneedling and nano-channeling industry; the demand for microneedling, nano-channeling, and combination treatment protocols amongst consumers; potential litigation involving SkinHealth Systems Inc.; changes in applicable laws or regulations; and the possibility that SkinHealth Systems Inc. may be adversely affected by other economic, business, and/or competitive factors. There may be additional risks that the Company does not presently know of or that the Company currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. SkinHealth Systems Inc. does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.
Contacts:
Press: press@skinhealthsystems.com
Investors: IR@skinhealthsystems.com
Source: SkinHealth Systems
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