FDA Product Code GEX: Powered Laser Surgical Instrument
Under FDA product code GEX, powered laser surgical instruments are cleared for use across a broad range of surgical applications.
These devices use focused light energy to cut, ablate, vaporize, or coagulate tissue with high precision and minimal thermal damage to surrounding structures. They are used in ophthalmology, dermatology, urology, and general surgery.
GEX devices are Class II medical devices, regulated under 21 CFR 878.4810 and reviewed by the FDA General & Plastic Surgery panel.
Leading manufacturers include Wontech Co., Ltd., Quanta System Spa and El.En S.P.A..
FDA 510(k) Cleared Powered Laser Surgical Instrument Devices (Product Code GEX)
About Product Code GEX - Regulatory Context
510(k) Submission Activity
2856 total 510(k) submissions under product code GEX since 1978, with 2856 receiving FDA clearance (average review time: 126 days).
Submission volume has increased in recent years - 153 submissions in the last 24 months compared to 121 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for GEX submissions have been consistent, averaging 119 days recently vs 126 days historically.
GEX devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →