The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Dermalogica for its PRO Pen Microneedling System, recognizing it as a Class II medical device. The authorization allows the company to market and distribute the PRO Pen in the United States next year and establishes a strong regulatory dossier to support future global rollouts.

True to Dermalogica’s heritage, the PRO Pen Microneedling System was designed with both patients and practitioners in mind. The PRO Pen Microneedling System introduces upgrades that elevate treatment outcomes and the in-office experience, according to the company.

“I am excited to have led the team responsible for FDA 510K Clearance of Dermalogica’s new Pro Pen Microneedling System,” said Robert J. Bianchini, Ph.D., vice president of Technology & Innovation at Dermalogica. “The updated design represents a true milestone in Dermalogica’s expansion into medical spas and follows closely behind our highly successful Exobooster Lactobacillus Exosome Treatment Serum. I want to thank our scientific team and our clinical partners at our parent company, Unilever (UL) for their support and guidance.” 

As consumer preference rises for less invasive, evidence-backed treatments and in-office solutions that deliver results without compromise, the PRO Pen Microneedling System positions Dermalogica at the forefront of next-generation medical aesthetics. The FDA clearance reinforces the brand’s role not only as a global authority in professional skincare, but a natural progression rooted in education, trust, and clinical excellence as a medical device innovator, Dermalogica bigwigs claim.

“Dermalogica has always advanced skin health, but FDA clearance marks our evolution into a new arena as a medical device innovator. By moving beyond traditional skincare and bringing our innovation mindset into medical aesthetics, we’re not just celebrating a brand milestone—we’re raising the bar for the entire industry with treatments practitioners are proud to deliver and consumers can truly trust,” Dermalogica CEO Aurelian Lis stated.

Used by skin care professionals worldwide, Dermalogica delivers skin treatment expertise. In 1983, founder Jane Wurwand identified a gap in professional skin care training and created the International Dermal Institute to provide advanced, post-graduate education. Wurwand launched Dermalogica in 1986, bucking the era’s industry trends in favor of clean formulas, a minimalist look, and commitment to skin health, not beauty.

Dermalogica today trains 100,000 skin therapists and professionals annually in advanced technologies and services. Products are formulated for the treatment room, used daily in the hands of licensed skin therapists and by millions of people for professional results at home. Headquartered in Los Angeles, Dermalogica sells products in more than 80 countries.