FDA device listing
Sunglasses (Non-Prescription Including Photosensitive)
FDA device listing 1640679477 · EVA OPTIKS, INC.
Key facts
| Owner/operator | EVA OPTIKS, INC. |
|---|---|
| Owner/operator number | 9007408 |
| Premarket submissions | K941047 |
| Product codes | HQY |
| Device names | HQY - Sunglasses (Non-Prescription Including Photosensitive) |
| Device class | Class I |
| Classification regulations (21 CFR) | 886.5850 |
| Review panels | Ophthalmic |
| Registered establishments | EVA OPTIKS, INC. |
| Establishment registrations | 9680236 |
| FEI numbers | 3002686669 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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