How to find a predicate device for a GEX 510(k)

Product code GEX covers laser therapy and surgical laser systems. There are 2,880 GEX clearances in the FDA 510(k) index we track, which makes it one of the deepest predicate pools in the database. This page shows you how to work that pool, with real recent clearances below.

What the GEX predicate pool looks like

Over the trailing 24 months to September 2026, FDA decided 148 GEX submissions: median review 90 days, 90th percentile 221 days. The most frequent clearers in the code are Cynosure (80 clearances on file), Sharplan Lasers (66), and Quanta System (57). A predicate search in GEX therefore starts from a large, active set of earlier clearances in the same product code.

Recent GEX clearances to investigate as predicates

Earlier clearances in the same product code are candidates to investigate, not predicate determinations. Verify any predicate claim against the official 510(k) summary.

• K261562, cleared 2026-09-10: Diode Laser Therapy System, Sanhe Lefis Electronics Co., Ltd.
• K262426, cleared 2026-09-10: Medical Diode Laser (S1Pro series), Wuhan Pioon Technology Co., Ltd.
• K261589, cleared 2026-09-02: 1927nm Thulium Laser System, Zhengzhou PZ Laser Slim Technology Co.
• K262269, cleared 2026-09-01: CO2 Laser System (MBT-CO2 Laser), Beijing Mega Beauty Technology Co., Ltd.
• K261821, cleared 2026-08-27: 1565nm Laser Therapy Device, Zhengzhou PZ Laser Slim Technology Co.

How to run the search

1. Enter your closest known 510(k) number in the free medical device predicate search. It pulls the FDA record and lists earlier same-code clearances as candidates.
2. Open each candidate's FDA record and read its 510(k) summary for the listed predicate. Only the summary establishes the relationship.
3. Watch the code afterward: see check any product code for the latest clearances, or read how competitive intelligence works.

Comparing codes? See the GEI predicate guide and the general how to find a predicate device for a 510(k) walkthrough.

Data: U.S. FDA via openFDA (public domain), plus our 510(k) index of 176,140 records and review benchmarks computed September 2026. Not regulatory advice. Assume all results are unvalidated.