A hand-held component of a professional, high-powered, dermatological laser system designed to both generate and direct a therapeutic laser (diode laser) for dermatological applications (e.g., hair removal, treatment of dermal lesions). This device is connecte
| Company | Devices | Share |
|---|---|---|
| Candela Corporation | 68 | 96% |
| Lumenis Be Ltd | 2 | 3% |
| Endymed Medical Ltd | 1 | 1% |
Company = labeler of record on GUDID. 3 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 | 85 |
Use these as the dimensions to specify in a tender line.
71 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dermatological laser beam producing handpiece", from 3 companies. The largest labeler is Candela Corporation with 96% of records.
GEX (Powered Laser Surgical Instrument)
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.