FDA device listing
Acuvue Oasys 12 Pack,Acuvue Oasys 24 Pack,Acuvue Oasys For Astigmatism,Acuvue Oasys Multifocal,Acuvue Oasys with…
FDA device listing 1546909896 · 1462287 BC Unlimited Liability Company
Key facts
| Proprietary names | Acuvue Oasys 12 Pack,Acuvue Oasys 24 Pack,Acuvue Oasys For Astigmatism,Acuvue Oasys Multifocal,Acuvue Oasys with Transitions |
|---|---|
| Owner/operator | 1462287 BC Unlimited Liability Company |
| Owner/operator number | 10092334 |
| Premarket submissions | P040045 |
| 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 | 1462287 BC UNLIMITED LIABILITY COMPANY |
| Establishment registrations | 3035373204 |
| FEI numbers | 3035373204 |
| Establishment operations | Foreign Exporter, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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