Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound Stimulator System for Aesthetic Use
fda-device · Food and Drug Administration · Rule · Published 2011-07-20 · Effective 2011-08-19 · 76 FR 43119
Document
Document number
2011-18278
Federal Register citation
76 FR 43119
CFR reference
21 CFR 878
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2011-07-20
Effective date
2011-08-19
HHS docket
Docket No. FDA-2011-N-0499
Abstract
The Food and Drug Administration (FDA) is classifying the focused ultrasound stimulator system for aesthetic use into class II (special controls). The special control(s) that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use." 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.