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Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

FDA product code ONF · 64 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4810
Review panel
SU
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2008-09-12 – 2026-06-12

A light based non-laser device that provides thermal effect including broad spectrum source devices such as intense pulse light (ipl). Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic. Indication for use can be general and/or specific.The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, or remove tissue by the light.

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