Medical Devices; General and Plastic Surgery Devices; Classification of the Low Level Laser System for Aesthetic Use
fda-device · Food and Drug Administration · Rule · Published 2011-04-14 · Effective 2011-05-16 · 76 FR 20840
Document
Document number
2011-8944
Federal Register citation
76 FR 20840
CFR reference
21 CFR 878
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2011-04-14
Effective date
2011-05-16
HHS docket
Docket No. FDA-2011-N-0188
Abstract
The Food and Drug Administration (FDA) is classifying the low level laser system for aesthetic use into class II (special controls). The special control(s) that will apply to the device is entitled "Class II Special Controls Guidance Document: Low Level Laser 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. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device type.