BeautyHealth’s SkinStylus™ Receives New FDA Clearance for Facial Acne Scarring
Now the only microneedling device FDA-cleared for use on both the face and abdomen
Milestone achievement in just five months since BeautyHealth’s acquisition of the brand
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SkinStylus™ (Photo: Business Wire)
The clearance from the FDA is a notable milestone for SkinStylus™ since its acquisition by BeautyHealth in February of this year, revealing of an ambitious and accelerated path for the brand since coming under BeautyHealth’s leadership.
“SkinStylus’ new facial indication for acne scarring is a testament to BeautyHealth’s innovation track record, proven brand building expertise, and our commitment to creating the future of skin health,” said BeautyHealth President and Chief Executive Officer
Expected to reach
Microneedling uses small needles to create tiny, controlled micro injuries that help trigger collagen and elastin production, which is essential for smoother, firmer, and more even-toned skin.
SkinStylus™ is an esthetician-founded brand, and the SkinStylus™ SteriLock® MicroSystem is designed to fit into the way medical and aesthetic professionals work, with a combined feature set they won’t find anywhere else.
Categorized by the FDA as a Class II Medical Device and under its new clearance, SkinStylus™ SteriLock® MicroSystem is intended to be used as a microneedling treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, and III in patients aged 22 years and older.
SkinStylus™ is already FDA-cleared for the indication to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years and older. This was supported by the clinical data that was submitted to FDA during the clearance process.
SkinStylus™ is available at providers across
Certain statements made in this release, including statements regarding the potential future market size for microneedling, are “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. 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 The Beauty Health Company’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements.
Important factors, among others, that may affect actual results or outcomes include The Beauty Health Company’s ability to execute its business plan; market demand for SkinStylus; the ability to effectively provide complementary beauty health products and services; potential litigation involving The