Medical devices; reclassification and codification of suction lipoplasty system for aesthetic body contouring--FDA. Final rule.
The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to the American Society for Aesthetic Plastic Surgery (ASAPS) reclassifying the suction lipoplasty system for use in aesthetic body contouring from class III (premarket approval) to class II (special controls). The reclassification is based on information regarding the device contained in a reclassification petition submitted by ASAPS and other publicly available information. Accordingly, the order is being codified in the Code of Federal Regulations. This action is taken under the Medical Device Amendments of 1976 (the 1976 amendments) as amended by the Safe Medical Devices Act of 190 (the SMDA).
D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards; D004864:Equipment and Supplies / Q000145:classification*; D006801:Humans; D015187:Lipectomy / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration