FDA device listing
Bovie J-Plasma Precise Open Handpiece,Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator,Footswitch Double…
FDA device listing 1453682679 · Apyx Medical Corporation
Key facts
| Proprietary names | Bovie J-Plasma Precise Open Handpiece,Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator,Footswitch Double Pedal J-Plasma Bovie Ultimate |
|---|---|
| Owner/operator | Apyx Medical Corporation |
| Owner/operator number | 10034275 |
| Product codes | GEI |
| Device names | GEI - Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4400 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Apyx Bulgaria Ltd. |
| Establishment registrations | 3004878380 |
| FEI numbers | 3004878380 |
| 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