The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Dermalogica’s 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.
“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,” says
Robert J. Bianchini, PhD, Vice President of Technology and Development at Dermalogica, in a news release.
