FDA device listing
AIR OPTIX AQUA ASTIGMATISM EW 6 PACK
FDA device listing 1319146021 · Fine Vision Optical Company
Key facts
| Proprietary names | AIR OPTIX AQUA ASTIGMATISM EW 6 PACK |
|---|---|
| Owner/operator | Fine Vision Optical Company |
| Owner/operator number | 10051792 |
| Premarket submissions | P010019 |
| Product codes | LPM |
| Device names | LPM - Lenses, Soft Contact, Extended Wear |
| Device class | Class III |
| Classification regulations (21 CFR) | 886.5925 |
| Review panels | Ophthalmic |
| Registered establishments | FINE VISION OPTICAL COMPANY |
| Establishment registrations | 3008504746 |
| FEI numbers | 3008504746 |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 10–99 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