An ophthalmic device consisting of a spectacle frame with a pair of optical spectacle lenses (typically made of plastic or glass, also known as eyeglasses) designed to be worn in front of the user's eyes to provide refractive corrections to eyesight conditions
| Company | Devices | Share |
|---|---|---|
| Fgx International Inc. | 43,891 | 73% |
| Kenmark Optical, Inc. | 13,336 | 22% |
| Clic Goggles Inc. | 777 | 1% |
| New International Vision | 754 | 1% |
| Zero G Eyewear | 547 | 1% |
| Bolle Brands (France) | 517 | 1% |
| Encore Vision, Inc. | 421 | 1% |
| Read On Inc. | 48 | 0% |
| Claudia Alan Inc | 23 | 0% |
| Solsolito Gmbh | 16 | 0% |
| Wenzhou Sunmax International Trade Co.,Ltd | 7 | 0% |
| Wal-Mart Stores, Inc. | 7 | 0% |
Company = labeler of record on GUDID. 18 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 |
|---|---|---|
| HOI | Spectacle, magnifying | 38,374 |
| HQZ | Frame, spectacle | 19,580 |
| HQZ | Frame, Spectacle | 1,727 |
| NJH | Lens, Spectacle (Prescription), For Reading Discomfort | 777 |
| HQG | Lens, Spectacle, Non-Custom (Prescription) | 525 |
| HOI | Spectacle, Magnifying | 98 |
Use these as the dimensions to specify in a tender line.
60,357 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Prescription spectacles", from 18 companies. The largest labeler is Fgx International Inc. with 73% of records.
HOI (Spectacle, magnifying), HQZ (Frame, spectacle), HQZ (Frame, Spectacle), NJH (Lens, Spectacle (Prescription), For Reading Discomfort)
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.