Dermalogica just announced the U.S. Food and Drug Administration (FDA) has granted them clearance for the PRO Pen Microneedling System as a Class II medical device. This new authorization comes after a rigorous regulatory process and multiple clinical studies. Ultimately, it will allow the company to market and distribute the PRO Pen Microneedling System in the U.S. beginning in 2026.
The Dermalogica PRO Pen Microneedling System was designed with both patients and practitioners in mind and has the power to upgrade and elevate in-office treatment outcomes. Vice-president of Technology & Innovation, Dr. Robert J. Bianchini, notes that this updated design marks a milestone expansion into medical spas, following in the footsteps of the brand’s Exobooster Lactobacillus Exosome Treatment Serum.
“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,” notes the brand in its press release.
“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 skin care 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,” says Executive Officer Aurelian Lis. The brand hopes to continue to bridge the gap between skin health and medical aesthetics by equipping professionals with advanced tools and education.
