FDA device listing
Optune Lua Treatment Kit
FDA device listing 1559307952 · A.L. ELECTRONICS LTD.
Key facts
| Proprietary names | Optune Lua Treatment Kit |
|---|---|
| Owner/operator | A.L. ELECTRONICS LTD. |
| Owner/operator number | 9048131 |
| Product codes | QGZ |
| Device names | QGZ - Electrical Tumor Treatment Fields |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.QGZ |
| Review panels | Anesthesiology |
| Registered establishments | A.L. ELECTRONICS LTD. |
| Establishment registrations | 3003639781 |
| FEI numbers | 3003639781 |
| 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