The Class II medical device will be available in the US starting in 2026, marking the company’s expansion into medical aesthetics.
Dermalogica has received 510(k) clearance from the US Food and Drug Administration (FDA) for its PRO Pen Microneedling System as a Class II medical device. The authorization permits the company to market the device in the United States beginning in 2026 and establishes a regulatory basis for future global distribution.
The clearance marks the skincare company’s entry into the medical device market. According to a company release, the PRO Pen Microneedling System was designed with both patients and practitioners in mind and introduces upgrades intended to elevate treatment outcomes and the in-office experience.
“Dermalogica has always advanced skin health, but FDA clearance marks our evolution into a new arena as a medical device innovator,” says Aurelian Lis, chief executive officer, in a 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.”
The company positions the new device as part of its expansion into medical spas, following its recently launched Exobooster Lactobacillus Exosome Treatment Serum.
Dermalogica plans to share additional details on the device’s features, training protocols, and specific availability early next year.
Photo caption: Dermalogica secures FDA 510(k) clearance for the PRO Pen Microneedling System.
Photo credit: Dermalogica
