Dermalogica Enters Medical Aesthetics with FDA-Cleared Microneedling PRO Pen

In a recent conversation with Dermatology Times, Michael Gold, MD, highlighted the clinical advantages of the Dermalogica PRO Pen microneedling device. Gold, founder of Gold Skin Care Center and the Tennessee Clinical Research Center in Nashville, emphasized the importance of FDA-cleared technologies and physician involvement in validating aesthetic devices and skin care systems.

According to Gold, one of the most critical differentiators for any microneedling device is FDA clearance. He stressed that the PRO Pen is a Class II medical device with its own 510(k) clearance, which he considers essential when evaluating safety and efficacy in clinical practice. While many devices on the market appear similar superficially, Gold noted that important distinctions exist in device engineering, treatment customization, and usability.

He explained that the PRO Pen offers variable speed settings, multiple cartridge configurations, and adjustable treatment depths, allowing clinicians to tailor procedures based on patient indication and treatment goals. The device can be used for superficial rejuvenation and skin brightening as well as deeper treatments targeting acne scarring, one of Gold’s primary areas of interest. He also highlighted ergonomic features, including a user-friendly grip and cartridges that visibly indicate treatment depth, which he said improve precision and workflow efficiency during procedures.

“Everything has been made very user-friendly, which sounds pretty simple, but in the needling world, that's pretty complicated to do,” Gold said. “So I think they've mastered that technique.”

The discussion also addressed the broader significance of Dermalogica launching its first FDA-cleared Class II medical device. Gold reflected on the company’s longstanding reputation within professional skin care, noting that he has worked with the brand for more than 30 years. He explained that while Dermalogica has historically been associated with professional skin care and later expanded into global retail markets, its move into the medical aesthetics space underscores the importance of collaborating with dermatologists and aesthetic professionals.

Gold emphasized that physician partnerships remain essential for validating new technologies and generating the clinical credibility necessary to distinguish evidence-based devices from marketing-driven products. He noted that aligning established skin care brands with dermatology expertise ultimately benefits both clinicians and patients by supporting safer, more effective aesthetic care.

“If you're taking a brand that already is well known in the skin care world, yet improving all the time, that's really good.” Gold said.

[This content is based on Dr. Gold’s medical opinion]