LUNA 3D Workstation Software
by L a P GmbH Laser Applikationen
LUNA 3D Workstation Software (0018438) is a Class II device made by L a P GmbH Laser Applikationen, cleared under FDA 510(k) K232031 on 29 Mar 2024 and listed in FDA GUDID since 17 Jun 2024 (UDI-DI 04260590372666), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04260590372666 | Date17 Jun 2024 | StatusListed |
| United States | FDA 510(k) | NumberK232031 | Date29 Mar 2024 | StatusActive |
Official records
- AccessGUDID record 04260590372666
- FDA 510(k) database K232031
Across registries
- FDA 510(k) K232031 decided 29 Mar 2024 Active
- FDA GUDID UDI-DI 04260590372666 listed 17 Jun 2024 Listed
Timeline
- Cleared FDA 510(k) K232031
- Listed FDA GUDID 04260590372666
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Luna 3D
- Generic name
- Radiological video camera patient positioning/tracking system
- Model / Ref / Catalog
- LUNA 3D Workstation Software, 0018438
- Primary DI / UDI-DI
- 04260590372666
- 510(k) Number
- FDA product code
- IYE
- GMDN term
- Radiological video camera patient positioning/tracking system
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code IYE (Accelerator, Linear, Medical).
- MUCHECK, VERSION 9.0 by Oncology Data Systems, Inc.
- MED-TEC RADIO THERAPY TREATMENT CHAIR by Medtec LLC
- BellySTEP Prone Position Pillow Cover P10107-167 by IT-V Medizintechnik GmbH
- CyberKnife Treatment Delivery System by Accuray Incorportaed
- BiomarC® Restore 040155 by Carbon Medical Technologies, Inc.
- ON-BOARD IMAGER DEVICE by Varian Medical Systems, Inc
- ELECTRON BEAM OPTION FOR CLINAC 15 MEV by Varian Assoc., Inc.
- RADCALC, MODEL V.4.0 by LifeLine Software
- DECISION SUPPORT SYSTEM (FOR RADIATION ONCOLOGY) by Multidata Systems International Corp.
- ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES by SIEMENS MEDICAL SOLUTIONS USA, INC.