Data / Medical devices / Powered Laser Surgical Instrument

Powered Laser Surgical Instrument (GEX): 366 FDA-registered makers in 29 countries

366 establishments in 29 countries are registered with the FDA to make Powered Laser Surgical Instrument (product code GEX, Class 2, 21 CFR 878.4810). 277 of them have a 510(k) clearance or PMA approval on file and 29 have a recall event. The FDA has issued 2,892 510(k) clearances under this code, the latest on October 22, 2026, and lists 101 recall events (2 Class I). FDA data exported November 2, 2026.

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Product code

GEX

Device class

2

Regulation

878.4810

Medical specialty

General, Plastic Surgery

Makers by country

Makers of Powered Laser Surgical Instrument

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated October 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.