FDA device listing
OmniGuide BeamPath® Fiber Optic HandPiece System
FDA device listing 1122333905 · Sanbor Medical
Key facts
| Proprietary names | OmniGuide BeamPath® Fiber Optic HandPiece System |
|---|---|
| Owner/operator | Sanbor Medical |
| Owner/operator number | 10028522 |
| Product codes | GEX |
| Device names | GEX - Powered Laser Surgical Instrument |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4810 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Sanbor Medical Xiamen, Inc. |
| Establishment registrations | 3007583504 |
| FEI numbers | 3007583504 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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