Dermalogica has officially launched the PRO Pen Microneedling System, marking the brand's first FDA-cleared device and its expansion into advanced in-office treatment technologies. The system, including the device and accessories, is intended to improve the appearance of facial acne scars in adults aged 22 and older.
Backed by over 40 years of skin health expertise, the PRO Pen is among a limited group of microneedling devices to receive FDA clearance in 2025, meeting rigorous regulatory standards for safety and performance. In parallel, Dermalogica has secured regulatory authorizations in key international markets. In Canada, ISO 13485 certification was obtained prior to device approval, establishing the company as a medical device manufacturer under internationally recognized quality systems. In Australia, clearance was achieved through a review of product labeling and compliance documentation aligned with U.S. authorization.
Following FDA clearance, the PRO Pen is now available to licensed skin health professionals. The device is designed for controlled skin penetration and manufactured in accordance with medical device standards, using biocompatible materials.
"Dermalogica has always been part of a professional ecosystem that bridges professional in-office treatments with at-home skincare. The PRO Pen extends this integration, enabling providers to design more comprehensive treatment journeys that support consistent outcomes while strengthening client loyalty and lifetime value," said Aurelian Lis, Dermalogica Chief Executive Officer.
The system integrates with Dermalogica's existing professional portfolio, allowing providers to expand service offerings and connect in-office procedures with prescribed homecare. This approach supports complete treatment plans, extending results beyond the treatment room and creating additional revenue opportunities through ongoing skincare regimens.
"We're encouraged by the progress we've made since receiving U.S. FDA 510(k) clearance for our 14-pin PRO Pen last fall. The response from the global professional skincare community and our dermatology partners has been extremely positive. When paired with our post-treatment Exo Booster system - featuring Lactobacillus-derived exosome-like vesicles - we're seeing consistent, clinically relevant improvements in acne scarring, skin texture, and overall dermal quality across a wide range of skin types," said Dr. Robert J. Bianchini, Ph.D., AAD.
Dr. Michael H. Gold, M.D., FAAD, added: "Dermalogica's 40+ year legacy in skin health is a key reason the Pro Pen was such a natural addition to my practice. It was one of the first cosmeceutical brands I brought into my office more than 30 years ago, and today it remains a name my patients recognize and trust. That level of brand equity makes integration seamless. The Pro Pen reflects that same standard - thoughtfully designed, easy to use, and able to deliver the precise depths needed for consistent, results-driven microneedling treatments."
The PRO Pen Microneedling System is now available through authorized Dermalogica professional channels.
Source: Read the original report | Published: April 28, 2026