Medical Devices; Reclassification and Codification of Suction Lipoplasty System for Aesthetic Body Contouring
fda-device · Food and Drug Administration · Rule · Published 1998-02-17 · Effective 1998-03-19 · 63 FR 7703
Document
Document number
98-3776
Federal Register citation
63 FR 7703
CFR reference
21 CFR 878
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1998-02-17
Effective date
1998-03-19
HHS docket
Docket No. 88P-0439
Abstract
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).