# P230042: Optune Lua

- Pathway: PMA
- Applicant: Novocure, GmbH
- Decided: Oct 15, 2024 after 305 days
- Product code: SDA (Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer)
- Device class: 3
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

Source page: https://510kreport.com/device/P230042
Methodology: https://510kreport.com/methodology