An electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to incise, excise, ablate, vaporize and coagulate tissues for general surgery and/or multiple specialized surgical appl
| Company | Devices | Share |
|---|---|---|
| Iridex Corporation | 87 | 30% |
| Medtronic Navigation, Inc. | 27 | 9% |
| Clinical Laserthermia Systems Ab | 26 | 9% |
| Medency Srl | 22 | 7% |
| Weinert Fiber Optics, Inc. | 20 | 7% |
| G.N.S Neolaser Ltd | 14 | 5% |
| Wuhan Gigaa Optronics Technology Co.,Ltd. | 9 | 3% |
| Triangel Rsd Limited | 8 | 3% |
| Dornier Medtech Gmbh | 7 | 2% |
| Alma Lasers Ltd. | 6 | 2% |
| Jiangxi Medex Technology Co., Ltd. | 4 | 1% |
| Cao Group, Inc. | 4 | 1% |
Company = labeler of record on GUDID. 44 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 | 207 |
| HQF | Laser, Ophthalmic | 60 |
| GEX | Powered laser surgical instrument | 44 |
| ONO | Neurosurgical laser with MR thermography | 21 |
| NVK | Laser, Dental, Soft Tissue | 12 |
| ILY | Lamp, Infrared, Therapeutic Heating | 9 |
Use these as the dimensions to specify in a tender line.
294 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General/multiple surgical diode laser system", from 44 companies. The largest labeler is Iridex Corporation with 30% of records.
GEX (Powered Laser Surgical Instrument), HQF (Laser, Ophthalmic), GEX (Powered laser surgical instrument), ONO (Neurosurgical laser with MR thermography)
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.