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In Brief: Lipoplasty device downclassification

This article was originally published in The Gray Sheet

Executive Summary

Final rule downclassifying suction lipoplasty systems for use in aesthetic body contouring from Class III to Class II published in the Feb. 17 Federal Register. The reclassification becomes effective March 19. FDA announced its intention to downclassify suction lipoplasty systems in November 1996 ("The Gray Sheet" Nov. 18, 1996, I&W-2). The agency issued the downclassification proposal based on findings in support of a 1989 recommendation by FDA's General and Plastic Surgery Devices Panel to downclassify the devices. The American Society for Aesthetic Plastic Surgery filed a petition in December 1988 requesting the downclassification...

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