Dermologica’s PRO Pen Microneedling System has been granted 501(k) clearance from the US Food and Drug Administration (FDA). This authorizes the technology as a Class II medical device “while also establishing a strong regulatory dossier to support future global rollouts,” according to the press release.
The PRO Pen Microneedling System was designed with both patients and providers in mind, advancing treatment outcomes and bettering the in-office experience. With the growing trend of patients wanting more non-invasive therapies, the PRO Pen meets that need with safe, evidence-backed results.
“Dermalogica has always advanced skin health, but FDA clearance marks our evolution into a new arena as a medical device innovator. 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 with treatments practitioners are proud to deliver and consumers can truly trust,” Aurelian Lis, Chief Executive Officer of Dermologica, said in a statement.
The PRO Pen is a dual modality system with SMART technology, 6 speeds (from 7500 to 8600 RPM), and 4 cartridge options to help each patient reach their unique skin goals. It also offers a nanofusion option to be paired with professional serums for enhanced product penetration. The cartridge types include 9-pin, 24-pin, nano metal, and nano silicon. The PRO Pen System can exfoliate even the most sensitive skin and is designed for patients looking for smoother, firmer, and more luminous skin while boosting hydration and fighting signs of aging.
The Microneedling System will be able to be distributed in the US next year and more details on features, protocols, training, and availability will be shared then. Today, the brand trains 100,000 skin therapists and clinical professionals per year in advanced technologies and aesthetic services. Products are sold to licensed providers and their patients in over 80 countries across the globe. Today’s milestone with the FDA supports Dermologica’s mission of advancing skin health through innovation and bridging this gap in medical aesthetics.
“I am excited to have led the team responsible for FDA 510K Clearance of Dermalogica’s new Pro Pen Microneedling System. The updated design represents a true milestone in Dermalogica’s expansion into Medical Spas and follows closely behind our highly successful Exobooster Lactobacillus Exosome Treatment Serum. I want to thank our scientific team and our clinical partners at our parent company, Unilever (UL) for their support and guidance,” Vice President of Technology & Innovation, Robert J. Bianchini, PhD, AAD, said in the press release.
