First Microneedling Device Approved by the FDA

Alex R. Thiersch | 3.28.18


It looks like there finally may be some clarity in the microneedling market. Bellus Medical recently announced that its mechanical micro-needling device, the SkinPen Precision System (often referred to as “SkinPen”), was approved by the FDA for the treatment facial acne scars in adults over the age of 22. This is a major development in the industry because, up until this approval, no mechanical device had been approved for microneedling in the U.S. This has caused tremendous confusion with the providers, and even some strongly worded letters from the FDA, as the market tried to determine whether to offer microneedling services.

The FDA’s approval of a microneedling device should offer guidance to the marketplace regarding what can and cannot be done with this treatment. Until now, many state medical and cosmetology boards have struggled to determine which practitioners could legally perform microneedling services. Many states – California and Illinois in particular – have been steadfast in holding that microneedling is a medical treatment to be performed only by nurses, physicians, or mid-level providers. While the FDA approval might not alter the treatment landscape in those states, it may offer guidance to other states determining how to categorize the device.

According to a press release from Bellus, the company “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.” The SkinPen is classified as a Class II medical device.

The press release can be read here.