FDA device listing
EyeQue VERAI,EyeQye PVT Lite,PVT Lite,VERAI
FDA device listing 1477412459 · EYEQUE
Key facts
| Proprietary names | EyeQue VERAI,EyeQye PVT Lite,PVT Lite,VERAI |
|---|---|
| Owner/operator | EYEQUE |
| Owner/operator number | 10052589 |
| Product codes | HKN |
| Device names | HKN - Refractor, Manual, Non-Powered, Including Phoropter |
| Device class | Class I |
| Classification regulations (21 CFR) | 886.1770 |
| Review panels | Ophthalmic |
| Registered establishments | EYEQUE CORPORATION |
| Establishment registrations | 3013003882 |
| FEI numbers | 3013003882 |
| Establishment operations | Manufacturer, Remanufacturer, Repackager/Relabeler, Specification Developer |
| 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