510(k) · Cleared
ClearedLUNA 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lap GmbH Laser Applikationen · IYE Accelerator, Linear, Medical
Cleared on Jun 4, 2026 as substantially equivalent to K233622 (Vision Rt, Ltd., 2024) after a 258-day review. Its family tree reaches back 10 generations to 1987.
- Decided
- Jun 4, 2026
- Review
- 258 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K864886 (1987). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK864886 Respigraph-Respisomnograph-RespicentralNims/Respitrace Corp. · 1987
- 6 generations between
- 3 generations backK203387 AlignRT PlusVision Rt, Ltd. · 2021
- 2 generations backK212583 AlignRT PlusVision Rt, Ltd. · 2021
- 1 generation backK233622 AlignRT PlusVision Rt, Ltd. · 2024
- This deviceK253004 LUNA 3DLap GmbH Laser Applikationen · 2026
Show all 10 generations
- Root · 10 generations backK864886 Respigraph-Respisomnograph-RespicentralNims/Respitrace Corp. · 1987
- 9 generations backK983629 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 1999
- 8 generations backK063270 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 2006 · Recalled
- 7 generations backK072171 Gatect-RTVision RT Limited · 2007
- 6 generations backK123371 Alignrt PlusVision RT Limited · 2013 · Recalled
- 5 generations backK181218 AlignRT PlusVision Rt, Ltd. · 2018
- 4 generations backK193431 AlignRT PlusVision Rt, Ltd. · 2020
- 3 generations backK203387 AlignRT PlusVision Rt, Ltd. · 2021
- 2 generations backK212583 AlignRT PlusVision Rt, Ltd. · 2021
- 1 generation backK233622 AlignRT PlusVision Rt, Ltd. · 2024
- This deviceK253004 LUNA 3DLap GmbH Laser Applikationen · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K864886 | Respigraph-Respisomnograph-Respicentral | Nims/Respitrace Corp. | 1987 | — |
| −9 | K983629 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 1999 | — |
| −8 | K063270 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 2006 | 1 |
| −7 | K072171 | Gatect-RT | Vision RT Limited | 2007 | — |
| −6 | K123371 | Alignrt Plus | Vision RT Limited | 2013 | 5 |
| −5 | K181218 | AlignRT Plus | Vision Rt, Ltd. | 2018 | — |
| −4 | K193431 | AlignRT Plus | Vision Rt, Ltd. | 2020 | — |
| −3 | K203387 | AlignRT Plus | Vision Rt, Ltd. | 2021 | — |
| −2 | K212583 | AlignRT Plus | Vision Rt, Ltd. | 2021 | — |
| −1 | K233622 | AlignRT Plus | Vision Rt, Ltd. | 2024 | — |
| 0 (this device) | K253004 | LUNA 3D | Lap GmbH Laser Applikationen | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 39 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 13 ancestors have a recall of any class.
- 1 other device also cites its predicate K233622.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253004 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253004: LUNA 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253004
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026