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 Mar 29, 2024 as substantially equivalent to K212583 (Vision Rt, Ltd., 2021) after a 266-day review. Its family tree reaches back 9 generations to 1987.
- Decided
- Mar 29, 2024
- Review
- 266 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K864886 (1987). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK864886 Respigraph-Respisomnograph-RespicentralNims/Respitrace Corp. · 1987
- 5 generations between
- 3 generations backK193431 AlignRT PlusVision Rt, Ltd. · 2020
- 2 generations backK203387 AlignRT PlusVision Rt, Ltd. · 2021
- 1 generation backK212583 AlignRT PlusVision Rt, Ltd. · 2021
- This deviceK232031 LUNA 3DLap GmbH Laser Applikationen · 2024
Show all 9 generations
- Root · 9 generations backK864886 Respigraph-Respisomnograph-RespicentralNims/Respitrace Corp. · 1987
- 8 generations backK983629 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 1999
- 7 generations backK063270 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 2006 · Recalled
- 6 generations backK072171 Gatect-RTVision RT Limited · 2007
- 5 generations backK123371 Alignrt PlusVision RT Limited · 2013 · Recalled
- 4 generations backK181218 AlignRT PlusVision Rt, Ltd. · 2018
- 3 generations backK193431 AlignRT PlusVision Rt, Ltd. · 2020
- 2 generations backK203387 AlignRT PlusVision Rt, Ltd. · 2021
- 1 generation backK212583 AlignRT PlusVision Rt, Ltd. · 2021
- This deviceK232031 LUNA 3DLap GmbH Laser Applikationen · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K864886 | Respigraph-Respisomnograph-Respicentral | Nims/Respitrace Corp. | 1987 | — |
| −8 | K983629 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 1999 | — |
| −7 | K063270 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 2006 | 1 |
| −6 | K072171 | Gatect-RT | Vision RT Limited | 2007 | — |
| −5 | K123371 | Alignrt Plus | Vision RT Limited | 2013 | 5 |
| −4 | K181218 | AlignRT Plus | Vision Rt, Ltd. | 2018 | — |
| −3 | K193431 | AlignRT Plus | Vision Rt, Ltd. | 2020 | — |
| −2 | K203387 | AlignRT Plus | Vision Rt, Ltd. | 2021 | — |
| −1 | K212583 | AlignRT Plus | Vision Rt, Ltd. | 2021 | — |
| 0 (this device) | K232031 | LUNA 3D | Lap GmbH Laser Applikationen | 2024 | — |
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K212583 | AlignRT PlusSummary page 5…osurgery treatments and CT simulation for radiation therapy planning. Predicate device: Device Name: AlignRT Plus 510k number: K212583 Device Classification Name: Medical charged-particle radiation therapy system Product Code: IYE C.F.R.… | 2021 |
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 37 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K212583.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 LAP 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. LAP LUNA 3D may also be used to guide patients through breath-holds.
The LAP LUNA 3D system can be used for all patients, undergoing radiotherapy and radiosurgery treatments and CT simulation for radiation therapy planning.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K232031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232031: LUNA 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232031
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026