Dermalogica PRO Secures FDA 510(k) Clearance for PRO Pen Micro-needling System

Dermalogica announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the PRO Pen Microneedling System as a Class II medical device. This authorization enables the company to market and distribute the PRO Pen in the United States beginning in 2026, while also establishing a strong regulatory dossier to support future global rollouts.

This milestone underscores Dermalogica's commitment to advancing skin health through science-backed innovation. Achieving clearance required a rigorous approach that combined precise regulatory planning, scientifically robust clinical studies, and strong alignment with FDA requirements.

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 meaningful upgrades that elevate treatment outcomes and the in-office experience.

"I am excited to have led the team responsible for FDA 510K Clearance of Dermalogica's new Pro Pen Microneedling System. 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" comments Robert J. Bianchini, Ph.D., AAD, Vice-President Technology & Innovation

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. This 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 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."- Aurelian Lis, Chief Executive Officer

Dermalogica's vision is to continuously bridge the gap between skin health and medical aesthetics by equipping professionals with advanced tools and education that deliver meaningful, safe, and science-driven results for every patient.

Additional details on features, training, protocols, and availability will be shared early next year.