A flexible, probe-like device intended to be connected to a surgical laser system to invasively direct and deliver laser energy for urogenital surgical applications, typically to haemostatically cut, coagulate, and vaporize prostate tissue to treat benign pros
| Company | Devices | Share |
|---|---|---|
| Weinert Fiber Optics, Inc. | 190 | 36% |
| Laser Peripherals, Llc | 129 | 24% |
| Quanta System Spa | 65 | 12% |
| Cook Incorporated | 22 | 4% |
| Maxiflex, Llc | 20 | 4% |
| Acquire Med | 19 | 4% |
| Fortec Fibers, Inc. | 18 | 3% |
| Coastal Life Technologies, Inc. | 15 | 3% |
| American Medical Endoscopy, Inc. | 13 | 2% |
| Laser Engineering | 8 | 2% |
| Coloplast A/S | 7 | 1% |
| Leoni Fiber Optics Gmbh | 6 | 1% |
Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| GEX | Powered laser surgical instrument | 401 |
| GEX | Powered Laser Surgical Instrument | 172 |
| KKX | Drape, surgical | 2 |
Use these as the dimensions to specify in a tender line.
532 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Urogenital surgical laser system beam guide, single-use", from 17 companies. The largest labeler is Weinert Fiber Optics, Inc. with 36% of records.
GEX (Powered laser surgical instrument), GEX (Powered Laser Surgical Instrument), KKX (Drape, surgical)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.