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 Asclepion Laser Technologies GmbH.
List of Powered Laser Surgical Instrument devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Powered Laser Surgical Instrument devices (product code GEX). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the General & Plastic Surgery FDA review panel. Browse all General & Plastic Surgery devices →