# K253004: LUNA 3D

- Pathway: 510(k) (Traditional)
- Applicant: Lap GmbH Laser Applikationen
- Decided: Jun 4, 2026 after 258 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K864886 (1987). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233622: AlignRT Plus, Vision Rt, Ltd. (2024) Summary page 7.

## Indications for use
The LUNA 3D system is used to support reproducible patient positioning and monitor patient surface motion during radiotherapy and radiosurgery treatments and during CT simulation for radiation therapy planning. The LUNA 3D system provides data exchange to radiotherapy imaging and radiotherapy treatment systems to synchronize image acquisition and treatment delivery. LUNA 3D may also be used to guide patients through breath-holds. The LUNA 3D system can be used for all patients, undergoing radiotherapy and radiosurgery treatments and CT simulation for radiation therapy planning.

Source page: https://510kreport.com/device/K253004
Methodology: https://510kreport.com/methodology