GEX

Powered Laser Surgical Instrument

Product code

GEX

Device name

Powered Laser Surgical Instrument

Device class

Class 2

21 CFR

21 CFR 878.4810

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

2876

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (221)

Last three years. Most recent: 2026-08-27.

183 summaries are archived here for direct download.

101 more not listed.