FDA device listing
Visitec Cellulose Eye Spear,Visitec Corneal Light Shield,Visitec LASIK Eye Drain (Banaji),Visitec LASIK PVA Expanded Eye…
FDA device listing 1266244988 · Beaver-Visitec International, Inc.
Key facts
| Proprietary names | Visitec Cellulose Eye Spear,Visitec Corneal Light Shield,Visitec LASIK Eye Drain (Banaji),Visitec LASIK PVA Expanded Eye Spear,Visitec LASIK PVA Eye Drain (Cheyet),Visitec LASIK PVA Eye Spears,Visitec Sponge,Visitec Visiwipe Instrument Wipes |
|---|---|
| Owner/operator | Beaver-Visitec International, Inc. |
| Owner/operator number | 10033379 |
| Premarket submissions | K933872 |
| Product codes | HOZ |
| Device names | HOZ - Sponge, Ophthalmic |
| Device class | Class II |
| Classification regulations (21 CFR) | 886.4790 |
| Review panels | Ophthalmic |
| Registered establishments | Beaver-Visitec International, Inc. |
| Establishment registrations | 1211998 |
| FEI numbers | 1211998 |
| Establishment operations | Manufacturer, Specification Developer |
| 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