Dermalogica’s PRO Pen Microneedling System FDA Cleared as a Class II Medical Device

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 marks Dermalogica’s first-ever medical aesthetics device as a predominantly skincare-focused brand.

“Dermalogica has always advanced skin health, but FDA clearance marks our evolution into a new arena as a medical device innovator,” Dermalogica CEO Aurelian Lis said in a press release. “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.”

Clearance allows Dermalogica to market and distribute the PRO Pen in the United States beginning in 2026. Additional details on features, training, protocols, and availability will be shared early next year.