Dermalogica PRO Pen Microneedling System has received U.S. Food and Drug Administration (FDA) 510(k) clearance. It merges science, safety, and innovation, delivering professional-grade, minimally invasive treatments. Read along to know more.
Dermalogica has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its PRO Pen Microneedling System. Now, the pen is officially classified as a Class II medical device. This milestone authorises U.S. marketing and distribution from 2026. Additionally, it lays the groundwork for future global launches.
The clearance reflects Dermalogica’s meticulous regulatory planning, robust clinical studies, and strict adherence to FDA requirements. It reinforces its reputation as a science-driven skincare innovator.
Next-generation microneedling innovation
Dermalogica designed the PRO pen with both patients and professionals in mind. The Pen offers advanced features to enhance treatment results and the in-office experience. As demand grows for minimally invasive, evidence-based skin treatments, Dermalogica’s PRO Pen positions the brand at the forefront of medical aesthetics. The system aligns with Dermalogica’s longstanding mission to blend skin health and medical aesthetics. It empowers professionals with cutting-edge tools and education to deliver safe, meaningful results.
Additional details on the PRO Pen’s features, protocols, and training will be released early next year.
From the leadership desk
“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”
– Robert J. Bianchini, Ph.D., AAD, Vice-President Technology & Innovation
“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
