GEX

2,872 FDA 510(k) clearances · Product code

FDA profile

Official device name

Powered Laser Surgical Instrument

Device class

Class II (moderate risk)

Regulation

21 CFR 878.4810

Medical specialty

General, Plastic Surgery

Flags

Third-party review eligible

FDA 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.

Adverse events (MAUDE)

2021: 3,465 · 2022: 2,288 · 2023: 2,337 · 2024: 2,251 · 2025: 2,831 · 2026: 1,785
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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