FDA device listing
Flexlens Adult Aphakic,Flexlens Aphakic,Flexlens ARC,Flexlens Keratoconus,Flexlens Piggyback,Flexlens Prism…
FDA device listing 1902691066 · Walman Optical
Key facts
| Proprietary names | Flexlens Adult Aphakic,Flexlens Aphakic,Flexlens ARC,Flexlens Keratoconus,Flexlens Piggyback,Flexlens Prism Sphere,Flexlens PRS,Flexlens Sphere,Flexlens Toric,Flexlens Tricurve Keratoconus,Westcon Horizon Adult Aphakic,Westcon Horizon Aphakic,Westcon Horizon Progressive,XRP Toric,XRP Toric Trial |
|---|---|
| Owner/operator | Walman Optical |
| Owner/operator number | 2125182 |
| Premarket submissions | K030593 |
| Product codes | LPL |
| Device names | LPL - Lenses, Soft Contact, Daily Wear |
| Device class | Class II |
| Classification regulations (21 CFR) | 886.5925 |
| Review panels | Ophthalmic |
| Registered establishments | X-CEL SPECIALTY CONTACTS |
| Establishment registrations | 1065845 |
| FEI numbers | 3003040707 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 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