HDE
H180002: Optune Lua
FDA Humanitarian Device Exemption · Novocure, GmbH
Key facts
| HDE number | H180002 |
|---|---|
| Trade name | Optune Lua |
| Generic name | Electrical tumor treatment fields |
| Applicant | Novocure, GmbH |
| Owner/operator | NOVOCURE GmbH |
| Product code | QGZ |
| Approval date | May 23, 2019 |
| Docket number | 19M-2522 |
| Notice date | May 24, 2019 |
| Establishment registration | 3010457505 |
| FEI number | 3010457505 |
At a glance
- 10–99 Supplements
- Jun 30, 2026 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 10–99 UDI device identifiers (GUDID)
- 1–9 MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: