K253004
- 510(k) number
- K253004
- Device name
- LUNA 3D
- Applicant
- Lap GmbH Laser Applikationen DE
- Product code
- IYE — Accelerator, Linear, Medical
- Decision date
- 2026-06-04
- Date received
- 2025-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253004.pdf
Official FDA record: K253004
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.