Medical Devices; General and Plastic Surgery Devices; Classification of Contact Cooling System for Aesthetic Use
Information
Type
Rule
Regulated products
Medical Devices
Published
February 7, 2011
Last updated
February 7, 2011
Description
Document number 2011-2552. The Food and Drug Administration (FDA) is classifying the contact cooling system for aesthetic use into class II (special controls). The special control that will apply to the device is the guidance document entitled "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use." The Agency is classifying the device into class II (special controls) in order to provide 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)