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Powered Laser Surgical Instrument

FDA product code GEX · 2779 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
1978-07-19 – 2026-09-24

A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.

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