510(k) K253004 · IYE Accelerator, Linear, Medical
LUNA 3D
| Applicant | Lap GmbH Laser Applikationen, Lüneburg, DE |
| Decision | Substantially Equivalent, Jun 4, 2026 |
| Received | Sep 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253004
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.