FDA device listing
Soflens Toric
FDA device listing 1124390080 · INFAR INTERNATIONAL PTE LTD
Key facts
| Proprietary names | Soflens Toric |
|---|---|
| Owner/operator | INFAR INTERNATIONAL PTE LTD |
| Owner/operator number | 10051977 |
| Premarket submissions | P960022 |
| Product codes | LPL, LPM |
| Device names | LPL - Lenses, Soft Contact, Daily Wear, LPM - Lenses, Soft Contact, Extended Wear |
| Device class | Class II, Class III |
| Classification regulations (21 CFR) | 886.5925 |
| Review panels | Ophthalmic |
| Registered establishments | INFAR INTERNATIONAL PTE LTD |
| Establishment registrations | 3009076545 |
| FEI numbers | 3009076545 |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 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