FDA device listing
Optune Lua
FDA device listing 1046377550 · NOVOCURE GmbH
Key facts
| Proprietary names | Optune Lua |
|---|---|
| Owner/operator | NOVOCURE GmbH |
| Owner/operator number | 10044866 |
| Premarket submissions | P230042 |
| Product codes | SDA |
| Device names | SDA - Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.SDA |
| Review panels | Anesthesiology |
| Registered establishments | NOVOCURE GMBH |
| Establishment registrations | 3010457505 |
| FEI numbers | 3010457505 |
| Establishment operations | Foreign Exporter, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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