Medical Devices; General and Plastic Surgery Devices; Classification of the Powered Surgical Instrument for Improvement in the Appearance of Cellulite
fda-device · Food and Drug Administration · Rule · Published 2014-06-03 · Effective 2014-07-03 · 79 FR 31859
Document
Document number
2014-12814
Federal Register citation
79 FR 31859
CFR reference
21 CFR 878
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2014-06-03
Effective date
2014-07-03
HHS docket
Docket No. FDA-2014-N-0576
Abstract
The Food and Drug Administration (FDA) is classifying the powered surgical instrument for improvement in the appearance of cellulite into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.