FDA Loosens Controls on Cellulite Treatment Devices

The Food and Drug Administration is formally reclassifying powered surgical instrument for improvement in the appearance of cellulite as Class II devices that do not require premarket approval, in an order that codifies a reclassification that took effect July 12, 2013. The devices had been classified in Class III, and required the filing of a premarket approval application before distribution. FDA is reclassifying them in response to a request from Cabochon Aesthetics related to the Cabochon System. Although they will no longer need FDA approval, the devices will still be subject to certain extra "special controls" related to testing and labeling. They will not be exempt from premarket notification requirements.