FDA device listing
Steriwave SW4000 Light Source
FDA device listing 1473781863 · Ondine Biomedical Inc.
Key facts
| Proprietary names | Steriwave SW4000 Light Source |
|---|---|
| Owner/operator | Ondine Biomedical Inc. |
| Owner/operator number | 10049666 |
| Product codes | MVF |
| Device names | MVF - System, Laser, Photodynamic Therapy |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.MVF |
| Review panels | General & Plastic Surgery |
| Registered establishments | ONDINE RESEARCH LABORATORIES/ONDINE BIOMEDICAL INC. (US) |
| Establishment registrations | 3006845489 |
| FEI numbers | 3006845489 |
| Establishment operations | U.S. Manufacturer of Export Only Devices |
| 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