Dermalogica Enters Device Market With FDA-Cleared Microneedling System

Key Takeaways

• Dermalogica has entered the medical device space with FDA clearance of its PRO Pen microneedling system.
• The device is indicated for improving the appearance of facial acne scars in adults aged 22 years and older.
• Regulatory approvals across the United States, Canada, and Australia reflect alignment with international device standards.

Dermalogica has announced the launch of its PRO Pen Microneedling System following US Food and Drug Administration (FDA) 510(k) clearance, marking the company’s first entry into the medical device category. The device is indicated for the treatment of facial acne scars in adults aged 22 years and older and is now available to licensed skin care professionals through authorized channels.

Microneedling devices are regulated as medical devices when intended for specific clinical indications, and FDA clearance requires demonstration of safety and performance relative to a predicate device. According to the company, the PRO Pen joins a limited number of microneedling systems cleared in 2025 for this indication. The device is designed to enable controlled skin penetration and is manufactured using biocompatible materials consistent with medical device standards.

In addition to US clearance, Dermalogica reported regulatory approvals in Canada and Australia. The company obtained ISO 13485 certification in Canada prior to device authorization, reflecting compliance with internationally recognized quality management systems for medical devices. Australian clearance was based on review of labeling and documentation aligned with US regulatory standards.

The PRO Pen is positioned within Dermalogica’s broader professional portfolio, which includes both in-office treatments and at-home skin care products. 

"Dermalogica's 40+ year legacy in skin health is a key reason the Pro Pen was such a natural addition to my practice,” Michael H. Gold, MD, FAAD, said. “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."