Medical Devices; Reclassification of Suction Lipoplasty System for Aesthetic Body Contouring

Samenvatting

The Food and Drug Administration (FDA) is issuing for public comment the recommendation of the General and Plastic Surgery Devices Panel (the Panel) to reclassify the suction lipoplasty system for aesthetic body contouring from class III to class II. The Panel made this recommendation after reviewing the reclassification petition submitted by the American Society for Aesthetic Plastic Surgery (ASAPS) and other publicly available information. FDA is also issuing for public comment its tentative findings on the Panel's recommendation. After considering any public comments on the Panel's recommendation and FDA's tentative findings, FDA will approve or deny the reclassification petition by order in the form of a letter to the petitioner. FDA's decision on the reclassification petition will be announced in the Federal Register.