Dermalogica Breaks New Ground with FDA-Approved Microneedling Device for Professionals
Iconic skincare brand Dermalogica has officially crossed the threshold from professional skincare into medical aesthetics with the full US launch of its PRO Pen Microneedling System — the brand’s first-ever FDA-cleared Class II medical device.
Launched in April 2026 following FDA 510(k) clearance granted in September 2025, the PRO Pen is now available to licensed skin health professionals across the United States. The device features cutting-edge SMART technology, six speed settings ranging from 7,500 to 8,600 RPM, and four interchangeable cartridge options, allowing clinicians to tailor treatments to each patient’s unique skin goals.
The PRO Pen is specifically cleared to improve the appearance of facial acne scars in adults aged 22 and older, and it also supports broader skin rejuvenation, texture improvement, and hydration. Dermalogica CEO Aurelian Lis described the launch as the brand’s “evolution into a new arena as a medical device innovator,” emphasizing that the clearance keeps advanced treatment in qualified professional hands at a time when unregulated devices are flooding the consumer market.
The move places Dermalogica — a brand owned by Unilever that trains over 100,000 skin therapists per year globally — within a select group of microneedling brands holding FDA clearance, alongside SkinPen and Rejuvapen NXT. Industry analysts project the global microneedling market will grow at a compound annual rate of 10.9%, reaching $1.1 billion by 2030.
Source: Dermatology Times – Dermalogica Enters Medical Aesthetics with FDA-Cleared Microneedling PRO Pen