An ophthalmic lens made of a treated glass or plastic intended to be worn in front of the eyes to attenuate rays of light by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections
| Company | Devices | Share |
|---|---|---|
| Pure Fishing, Inc. | 423 | 36% |
| New York Eye | 295 | 25% |
| Eagle Eyes | 234 | 20% |
| Active Brands North America Inc | 95 | 8% |
| Zoom Eyeworks Dba Icu Eyewear, Inc. | 90 | 8% |
| Rxsight, Inc. | 12 | 1% |
| Optego Vision Usa Inc. | 10 | 1% |
| Masunaga Optical Mfg.Co.,Ltd. | 9 | 1% |
| La Giardiniera Srl | 3 | 0% |
| Fresnel Prism & Lens Company | 2 | 0% |
Company = labeler of record on GUDID. 10 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 |
|---|---|---|
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | 695 |
| HQY | Sunglasses (non-prescription including photosensitive) | 513 |
| HOI | Spectacle, magnifying | 90 |
| HQZ | Frame, Spectacle | 27 |
| HOI | Spectacle, Magnifying | 10 |
| HQG | Lens, Spectacle, Non-Custom (Prescription) | 3 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
1,173 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Tinted non-prescription spectacle lens", from 10 companies. The largest labeler is Pure Fishing, Inc. with 36% of records.
HQY (Sunglasses (Non-Prescription Including Photosensitive)), HQY (Sunglasses (non-prescription including photosensitive)), HOI (Spectacle, magnifying), HQZ (Frame, Spectacle)
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.