FDA device listing
QUAY EYEWEAR, MARCOLIN, SAFILO USA, FOSSIL, MOREL EYEWEAR, ALLURE
FDA device listing 1222315050 · OKIA OPTICAL CO., LTD.
Key facts
| Proprietary names | QUAY EYEWEAR, MARCOLIN, SAFILO USA, FOSSIL, MOREL EYEWEAR, ALLURE |
|---|---|
| Owner/operator | OKIA OPTICAL CO., LTD. |
| Owner/operator number | 9036745 |
| Product codes | HOY |
| Device names | HOY - Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) |
| Device class | Class I |
| Classification regulations (21 CFR) | 886.4750 |
| Review panels | Ophthalmic |
| Registered establishments | OKIA OPTICAL CO., LTD. |
| Establishment registrations | 9617805 |
| FEI numbers | 3007413391 |
| Establishment operations | Foreign Exporter, Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database