Data / Medical devices / Israel / Novocure Ltd
Novocure Ltd: FDA-registered device maker in Haifa Northern, Israel, 3 PMA approvals
Novocure Ltd is registered with the FDA (registration 3009453079) in Haifa Northern, Israel. It lists 4 device types. The FDA files 3 PMA approvals under its listings, the newest dated February 11, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009453079
- Address
- Topaz Bldg., Matam Center, Haifa Northern, Israel, 3190500
- Owner or operator
- Novocure Ltd (10039906)
- Roles
- Specification developer
- First device listed
- February 21, 2012
- Registered through
- 2026
- Brand names listed
- Optune Lua Treatment Kit, Optune Lua for NSCLC, Optune Pax, Optune Treatment Kit, Transducer Array
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrical Tumor Treatment Fields | QGZ | 3 | Specification developer | accessdata.fda.gov |
| Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer | SDA | 3 | Specification developer | accessdata.fda.gov |
| Low Electric Field Generator For Pancreatic Cancer Treatment | SHC | 3 | Specification developer | accessdata.fda.gov |
| Stimulator, Low Electric Field, Tumor Treatment | NZK | 3 | Specification developer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 11, 2026 | P250034 | Optune Pax | SHC | 1 | July 1, 2026 | accessdata.fda.gov |
| October 15, 2024 | P230042 | Optune Lua | SDA | 6 | July 1, 2026 | accessdata.fda.gov |
| April 8, 2011 | P100034 | NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT | NZK | 45 | September 18, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer
- All makers of Low Electric Field Generator For Pancreatic Cancer Treatment
- All makers of Stimulator, Low Electric Field, Tumor Treatment
- All makers of Electrical Tumor Treatment Fields
Updated July 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.