‘SkinPen’ Doesn’t Merit Dermabrasion Exemption, Warning Letter Says

A March FDA inspection found that Bellus Medical marketed and distributed its SkinPen device without approved premarket clearance or an investigational device exemption.

As such, the agency deemed the SkinPen dermabrasion product adulterated because the Dallas-based firm did not notify the FDA that it intended to commercialize its device.

The SkinPen device is an automated, nonsurgical “microneedling” device designed to improve the appearance of wrinkles and scars by delivering “thousands of micro-injuries to the skin,” the  warning letter said.