An assembly of devices designed to produce and control the delivery of high heat (i.e., temperatures greater than 43? Celsius) to the body using ultrasonic energy for the intracorporeal or extracorporeal treatment of malignant or benign tumours, or other disea
| Company | Devices | Share |
|---|---|---|
| Alma Lasers Ltd. | 47 | 89% |
| Focus Surgery Inc | 4 | 8% |
| Insightec Ltd | 2 | 4% |
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 |
|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 22 |
| GEX | Powered Laser Surgical Instrument | 16 |
| PLP | High Intensity Ultrasound System For Prostate Tissue Ablatio | 4 |
| NUV | Massager, Vacuum, Light Induced Heating | 4 |
| HQF | Laser, Ophthalmic | 3 |
| POH | Mr-Guided Focused Ultrasound System | 2 |
Use these as the dimensions to specify in a tender line.
53 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ultrasonic hyperthermia system", from 3 companies. The largest labeler is Alma Lasers Ltd. with 89% of records.
GEI (Electrosurgical, Cutting & Coagulation & Accessories), GEX (Powered Laser Surgical Instrument), PLP (High Intensity Ultrasound System For Prostate Tissue Ablatio), NUV (Massager, Vacuum, Light Induced Heating)
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.