Medical Devices; General and Plastic Surgery Devices; Classification of the Low Level Laser System for Aesthetic Use
Information
Type
Rule
Regulated products
Medical Devices
Published
April 14, 2011
Last updated
April 14, 2011
Description
Document number 2011-8944. 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)