SkinPen Precision is the only device with this new classification, established by the FDA, making it the only legally marketed microneedling device in the U.S. – truly a category of one.SkinPen Precision is officially the ONLY Class II, FDA cleared microneedling device on the market.

This is the first and only microneedling device in the industry to receive this important designation from the U.S. Food and Drug Administration (FDA), and sets a new standard as the only recognized Class II microneedling device available.

"FDA clearance for SkinPen Precision demonstrates our unwavering commitment to the safety, quality and excellence needed to elevate the standards in the microneedling industry," said Joe Proctor, Bellus Medical President and CEO. "With this recognition by the highest organization in the U.S., the FDA, healthcare providers and consumers know they can trust SkinPen Precision and Bellus Medical to create, develop and manufacture the safest and most cutting-edge solutions on the market."

Proactive Clinical Evaluation and Proven Results to receive this first-in-class FDA designation, Bellus Medical proactively worked through a rigorous three-year evaluation process to meet more than 90 validated requirements for the microneedling device, charger base and proprietary cartridge, including extensive biocompatibility testing to ensure none of the materials are harmful to patients' skin cells.

"Our evaluation process with the FDA resulted in a new draft guidance issued by the FDA, which includes regulatory requirements for microneedling devices," said Jennifer Block, Bellus Medical Director of Quality & Regulatory. "Our steadfast focus on healthcare provider and patient safety resulted in a new classification for microneedling devices. Bellus Medical's SkinPen Precision is truly leading the industry as the only microneedling system on the market meeting the FDA's new standards.

"Healthcare Providers and Patients Choose SkinPen® Precision Bellus Medical collaborated with some of the world's leading experts in the medical aesthetics industry, dermatology and plastic surgery to help identify the safety risks associated with microneedling devices.

This feedback, along with the SkinPen Precision clinical trials, helped Bellus Medical implement measures to prevent risks to healthcare providers and consumers.