A handpiece that is part of a skin surface treatment system that conducts one or more generated light energies [e.g., fluorescent, ultraviolet B (UVB)] used for ablative and non-ablative treatment of skin conditions (e.g., acne, psoriasis, vascular lesions, wr
| Company | Devices | Share |
|---|---|---|
| Quanta System Spa | 44 | 49% |
| Formatk Systems Ltd | 15 | 17% |
| Venus Concept Ltd | 7 | 8% |
| Cutera, Inc. | 6 | 7% |
| Cynosure, Llc | 5 | 6% |
| Bemer Int. Ag | 3 | 3% |
| Luma Therapeutics, Inc. | 2 | 2% |
| Advance-Esthetic Llc | 2 | 2% |
| Dynatronics Corporation | 2 | 2% |
| Vydence Medical | 2 | 2% |
| E-Swin | 1 | 1% |
| Biotec Italia Srl | 1 | 1% |
Company = labeler of record on GUDID. 12 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 | 63 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Therm | 30 |
| GEX | Powered laser surgical instrument | 5 |
| ILY | Lamp, Infrared, Therapeutic Heating | 4 |
| OHS | Light Based Over The Counter Wrinkle Reduction | 3 |
| OLP | Over-The-Counter Powered Light Based Laser For Acne | 3 |
Use these as the dimensions to specify in a tender line.
90 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Light-energy skin surface treatment system applicator", from 12 companies. The largest labeler is Quanta System Spa with 49% of records.
GEX (Powered Laser Surgical Instrument), ONF (Powered Light Based Non-Laser Surgical Instrument With Therm), GEX (Powered laser surgical instrument), ILY (Lamp, Infrared, Therapeutic 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.