PRO Pen launches in 2026, expanding Dermalogica’s skincare innovation into device-based care.
Courtesy of Micro2ndDesigns at Adobe Stock
Dermalogica has gained FDA clearance for its first-ever medical aesthetics device as a predominantly skincare-focused brand. Clearance for the class II device, as of Sept. 10, prompts the distribution of the PRO Pen Microneedling System in the United States beginning in 2026.
Log in to view the full article
Dermalogica has gained FDA clearance for its first-ever medical aesthetics device as a predominantly skincare-focused brand. Clearance for the class II device, as of Sept. 10, prompts the distribution of the PRO Pen Microneedling System in the United States beginning in 2026.
The microneedling system, per a Sept. 10 press release, materialized to meet consumers' increasing preference for less invasive solutions. In 2024, TheAmerican Academy of Facial Plastic and Reconstructive Surgery recorded 83% of procedures performed in 2023 were minimally invasive, while the remaining 17% were surgical [1]. The top three most common treatments were neurotoxins, fillers and topical treatments, specifically microneedling and chemical peels.PRO Pen Microneedling SystemCourtesy of Dermalogica Sept. 10 Press Release
Minimally invasive procedures have since continued to rise, especially with patients using weight loss medications [2] and turning to microneedling, among other solutions, to address the skin laxity, volume loss and sagging by stimulating collagen and elastin production after rapid weight loss.
To achieve clearance from the FDA, Dermalogica conducted regulatory planning and clinical studies. Dermalogica is a brand typically associated with skincare products, and this clearance marks its first medical aesthetics device, as skincare solutions interconnect more closely with devices for patients, and skin products, such as serums and other actives, are pentrated into the skin via microneedling [3].
"FDA clearance marks our evolution into a new arena as a medical device innovator,” said Aurelian Lis, CEO of Dermalogica. “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.”
