510(k) · Cleared
ClearedLumenon Xenon Light Source
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Walter Lorenz Surgical, Inc. · GCT Light Source, Endoscope, Xenon Arc
Cleared on Sep 14, 1999 after an 89-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Sep 14, 1999
- Review
- 89 days
- Class
- Class II
- Product code
- GCT
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK992050 Lumenon Xenon Light SourceWalter Lorenz Surgical, Inc. · 1999
- Descendant · cites it directly · 2 of its ownK013880 Daylite Xenon Light SourcesDesigns For Vision, Inc. · 2001
- Descendant · 2 generations on · 1 of its ownK032283 Designs for Vision Fiberoptic LightDesigns For Vision, Inc. · 2003
- Descendant · 3 generations on · 0 of its ownK051786 Melide Fiberoptic LightDesigns For Vision, Inc. · 2005
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992050 | Lumenon Xenon Light Source | Walter Lorenz Surgical, Inc. | 1999 | — |
| +1 | K013880 | Daylite Xenon Light Sources | Designs For Vision, Inc. | 2001 | — |
| +2 | K032283 | Designs for Vision Fiberoptic Light | Designs For Vision, Inc. | 2003 | — |
| +3 | K051786 | Melide Fiberoptic Light | Designs For Vision, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 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 GCT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | — | Welch Allyn Xenon 300 Light Source Named without a submission number | |
| * | — | Xenon Light Source Model LS 6035 Named without a submission number | |
| * | — | other legally marketed Xenon Light Sources Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013880 | Daylite Xenon Light Sources | 2001 | 2 |
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?
- Of its descendants, K013880 (Designs For Vision, Inc., 2001) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GCT devicesGCT Light Source, Endoscope, Xenon Arc: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCT
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · GCT
Too few GCT 510(k)s in any year since 2007 to give a median.
Recalls per year · GCT
No recall names GCT since 2007.
Adverse event reports per year · GCT
347in 2025
MAUDE reports naming product code GCT, 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 | 1 | — | 0 | 32 |
| 2008 | 1 | — | 0 | 29 |
| 2009 | 0 | — | 0 | 153 |
| 2010 | 1 | — | 0 | 21 |
| 2011 | 0 | — | 0 | 132 |
| 2012 | 0 | — | 0 | 36 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 11 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 15 |
| 2017 | 0 | — | 0 | 14 |
| 2018 | 0 | — | 0 | 20 |
| 2019 | 0 | — | 0 | 18 |
| 2020 | 0 | — | 0 | 114 |
| 2021 | 0 | — | 0 | 149 |
| 2022 | 0 | — | 0 | 158 |
| 2023 | 0 | — | 0 | 200 |
| 2024 | 0 | — | 0 | 296 |
| 2025 | 0 | — | 0 | 347 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Lumenon Xenon Light Source is intended to
supply adjustable high intensity illumination for accessories such as
headlights and endoscopes.
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/K992050 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992050: Lumenon Xenon Light Source.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992050
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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