FDA Product Code GEX Explained (Powered Laser Surgical Instrument)

GEX is the FDA product code for “Powered Laser Surgical Instrument” — a Class II device under 21 CFR 878.4810, in the General & Plastic Surgery panel, reviewed through the 510(k) pathway. You can confirm the entry yourself in the product classification database or via openFDA.

• Diode, alexandrite, and Nd:YAG hair removal lasers (professional use) — hair removal appears in the indications for use
• Surgical and dermatological lasers for cutting, coagulation, and removal of tissue
• Many multi-application “platform” lasers sold to clinics

The detail most buyers miss: there is no dedicated product code for professional hair removal lasers. Unlike home-use devices (which have their own OTC code, OHT — see our IPL product codes page), professional hair removal machines are cleared under GEX with hair removal named in the cleared indications. So the right check is not “find a hair removal code” but “find a GEX clearance whose indications include hair removal”.

Clearance under GEX is achievable for non-US manufacturers — the public 510(k) database shows dozens of examples. A few public entries (verifiable directly in the 510(k) database):

We list these as neutral, public examples of how GEX entries look — not as recommendations. Each entry is worth opening: note that the applicant is the manufacturer entity, the device name matches a specific model, and the decision letter (available for many entries) shows the cleared indications.

• In the 510(k) database, search by product code GEX plus a keyword such as “hair removal”.
• For a supplier claim, jump straight to their K number and check the product code field shows GEX, the applicant matches the manufacturer, and the indications cover your treatment.
• Cross-check the device listing in the registration & listing database shows the same code.

For the full code map of the aesthetic industry, see the cheat sheet; for what the whole process involves, see 510(k) clearance for aesthetic lasers.

Last updated: October 11, 2026. Product codes and regulatory references were verified against official FDA sources (openFDA / accessdata.fda.gov) on this date. This page provides general purchasing information, not legal advice; regulations change, so confirm requirements at the time you buy.

Working with multiple suppliers and want a second pair of eyes on specifications and market availability? contact the LEIJEX team or review our manufacturing and quality system.