Product code GEX: 510(k) clearances and predicates
Product code GEX covers PicoreMax (PicoreMax). FDA lists 2887 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
2887 clearances on file under product code GEX. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 60 |
| 2023 | 52 |
| 2024 | 82 |
| 2025 | 83 |
| 2026 so far | 52 |
Recent clearances
Newest GEX clearances in the FDA index, with applicant and decision date:
- K254199, PicoreMax (PicoreMax), applicant BLUECORE COMPANY Co., Ltd., decided 2026-09-24. FDA record
- K252723, Dynamis Pro Family, applicant Fotona D.O.O., decided 2026-09-19. FDA record
- K241973, SmartIPL_NI System, applicant Lumenis Be, Ltd., decided 2026-09-19. FDA record
- K261047, Dental Diode Laser Device (Laser-Pen), applicant Guilin Kevin Peter Technology Co., Ltd., decided 2026-09-18. FDA record
- K261817, Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02), applicant Zhengzhou PZ Laser Slim Technology Co., Ltd., decided 2026-09-17. FDA record
- K261673, LED Therapy Device (QLXY-01), applicant Beijing Nubway S&T Co., Ltd., decided 2026-09-17. FDA record
- K262877, SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories), applicant Olympus Surgical Technologies America, decided 2026-09-16. FDA record
- K262426, Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75), applicant Wuhan Pioon Technology Co., Ltd., decided 2026-09-10. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Dynamis Pro Family, SmartIPL_NI System. Watch new GEX clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code GEX?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent GEX clearances include PicoreMax (PicoreMax).
How many 510(k) clearances use product code GEX?
2887 at the time this page was generated, from openFDA records.
How do I find a predicate device under GEX?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new GEX clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.