Microneedling has come of age in the medical aesthetic arena as SkinPen® from Bellus Medical (Addison, Texas) recently announced that it is the first and only microneedling system to receive a De Novo clearance as a Class II medical device by The Food and Drug Administration (FDA). This designation grants the company clearance and marketing authorization for the device, which is intended to improve the appearance of facial acne scars in adults aged 22 years or older. This clearance was based on the FDA’s recently codified language regarding aesthetic uses of microneedling.
The bottom line for aesthetic practices: SkinPen is the first and only microneedling system to receive this type of clearance.
SkinPen has also set a new technological and safety standard for microneedling, offering minimally invasive, non-ablative options utilizing state-of-the-art skin rejuvenating technology. Employing straight needles that penetrate at a 90° angle, SkinPen creates hundreds of vertical microscopic channels in the dermis to trigger skin remodeling without causing scar tissue formation.
FDA Clearance Wins Physician Support
According to Mary Lupo, M.D., a dermatologic surgeon in New Orleans, La., “It is significant that SkinPen is the only microneedling product on the market that is cleared for use in both the U.S. and Europe. I was attracted to SkinPen because I know that the procedure has been scientifically proven for safety and efficacy. I appreciate the expense of such a process and the commitment to safe results.”
As noted by Steven Dayan, M.D., a plastic and cosmetic surgeon in Chicago, Ill., “We had heard about SkinPen’s development and were holding out for the FDA clearance. When it came, that gave us a boost and created a new initiative to get started with SkinPen.”
Dr. Dayan added, “We do a lot of training and there has been a lot of interest from physicians about microneedling, mainly its efficacy and safety. With SkinPen and its FDA clearance, we were able to teach more about this type of approach. The device gets a ton of use in my practice between me and my aestheticians, medical assistants and PAs. They love it.”
As reported by Joe Proctor, president & CEO of Bellus Medical, “The procedure has virtually no downtime and a very good adverse event profile. In fact, in our clinical study we had zero adverse events tied to the actual device. In addition, SkinPen is safe on all skin types.”
As many aesthetic physicians have expressed interest in adopting microneedling, Mr. Proctor considers SkinPen to be a gateway productthat would bring in new patients. “This is for the patient that comes into a clinic and asks, ‘Can I get an aesthetic procedure that achieves real results and improves the look of my skin?’ SkinPen is available by prescription only and is a Class II medical device. Both of these aspects protect the practice,” he stated.