Identity
- Trade Name
- Optune Lua FDA PMA
- Generic Name
- Electrical tumor treatment fields for non-small cell lung cancer FDA PMA
Identifiers
- PMA Number
- P230042 FDA PMA
- FDA Product Code
- SDA FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Anesthesiology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
Optune Lua is an electrical tumor treatment field device designed for the management of metastatic non-small cell lung cancer. It functions by delivering electrical fields to the tumor site to assist in treatment protocols.
This device is indicated for use in adult patients who have progressed on or after a platinum-based regimen. It is intended to be used concurrently with PD-1/PD-L1 inhibitors or docetaxel as part of a prescribed therapeutic plan.
Frequently asked questions
What is the primary indication for Optune Lua?
Optune Lua is indicated for adult patients diagnosed with metastatic non-small cell lung cancer who have experienced disease progression following a platinum-based chemotherapy regimen.
How is Optune Lua administered in a treatment plan?
The device is used concurrently with other prescribed therapies, specifically PD-1/PD-L1 inhibitors or docetaxel, to treat metastatic non-small cell lung cancer.
What type of technology does Optune Lua use?
Optune Lua utilizes electrical tumor treatment fields, which are designed to target cancer cells as part of a specialized medical treatment approach.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NSCLC Treatment | Optune Lua®, Press Releases - Investor Relations | Novocure GmbH, Novocure Announces Optune Lua® Receives Reimbursement ..., Optune Lua® video library, Novocure's Optune Lua device generates TTFields to treat non ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Active |
| FDA PMA | United States | FDA_PMA | P230042 | Class III | Active |
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Manufacturer
- Manufacturer
- Novocure GmbH
- FDA Applicant
- Novocure, GmbH
Sources (2)
- FDA PMA P230042 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 17, 2026