Medical Devices; General and Plastic Surgery Devices; Classification of the Electrosurgical Device for Over-the-Counter Aesthetic Use
fda-device · Food and Drug Administration · Rule · Published 2016-06-29 · Effective 2016-06-29 · 81 FR 42243
Document
Document number
2016-15381
Federal Register citation
81 FR 42243
CFR reference
21 CFR 878
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2016-06-29
Effective date
2016-06-29
HHS docket
Docket No. FDA-2016-N-1618
Abstract
The Food and Drug Administration (FDA) is classifying the electrosurgical device for over-the-counter aesthetic use into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the electrosurgical device for over-the-counter aesthetic use's classification. 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.