FDA device listing
BlueGuard,CleanGuard,ClearMind,ClearView,DriveSafe,DuraVision,Experience 4K,GT2,Light,Performance HD,Performance…
FDA device listing 1157202225 · CARL ZEISS VISION INC.
Key facts
| Proprietary names | BlueGuard,CleanGuard,ClearMind,ClearView,DriveSafe,DuraVision,Experience 4K,GT2,Light,Performance HD,Performance HDV,PerformaSun,PhotoFusion,SmartLife,Synchrony,Ultra HD,Ultra HDV,UVProtect,ZEISS,ZEISS Optical Insert,ZEISS Optical Insert - Demo,ZEISS Optical Insert- Prescription,ZEISS Optical Insert- Reader,ZEISS XRRX Insert |
|---|---|
| Owner/operator | CARL ZEISS VISION INC. |
| Owner/operator number | 9086547 |
| Product codes | HQG |
| Device names | HQG - Lens, Spectacle, Non-Custom (Prescription) |
| Device class | Class I |
| Classification regulations (21 CFR) | 886.5844 |
| Review panels | Ophthalmic |
| Registered establishments | Carl Zeiss Vision Canada, Inc., CARL ZEISS VISION (CHINA) LTD., Carl ZEISS Vision Inc. - USRX-SC, CARL ZEISS VISION ITALIA S.P.A., CARL ZEISS VISION MANUFACTURA DE MEXICO, S. DE R.L, CARL ZEISS VISION SUNLENS ASIA PACIFIC LTD., Carl Zeiss Vision Technologies (Guangzhou) Ltd. |
| Establishment registrations | 9616418, 1000253285, 3003344414, 3003461935, 3007675955, 3007774522, 3011589232 |
| FEI numbers | 1000253285, 3003344414, 3003461935, 3005625913, 3007675955, 3007774522, 3011589232 |
| Establishment operations | Manufacturer |
| 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