510(k) Report

510(k) · Cleared

Cleared

Xenon Light Source Model LS6000

K981804510(k) TraditionalCleared Jul 24, 199864-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Contec Medical Vision, Ltd. · GCT Light Source, Endoscope, Xenon Arc

Cleared on Jul 24, 1998 as substantially equivalent to K944821 (Richard Wolf Medical Instruments Corp., 1994) and 2 other predicates after a 64-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.

Decided
Jul 24, 1998
Review
64 days
Class
Class II
Product code
GCT
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K944821 (1994). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1994: 1 other ancestor1998: 1 descendant clearedK944821 · MODEL 5151 · Richard Wolf Medical Instruments Corp. · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant K944821 · MODEL 5151 · Richard Wolf Medical Instruments Corp. · 19940
  1. Root · 1 generation backK944821 MODEL 5151Richard Wolf Medical Instruments Corp. · 1994
  2. This deviceK981804 Xenon Light Source Model LS6000Contec Medical Vision, Ltd. · 1998
  3. Descendant · cites it directly · 0 of its ownK982962 Xenon Light Source, Models LS6180, LS6035Contec Medical Vision, Ltd. · 1998

Most influential descendants

Showing 1 of 1 · See all
  • K982962Xenon Light Source, Models LS6180, LS6035Contec Medical Vision, Ltd. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K944821MODEL 5151Richard Wolf Medical Instruments Corp.1994—
0 (this device)K981804Xenon Light Source Model LS6000Contec Medical Vision, Ltd.1998—
+1K982962Xenon Light Source, Models LS6180, LS6035Contec Medical Vision, Ltd.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K981804, 1994–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K944821MODEL 5151
Summary page 1
…The Xenon Light Source Model LS 6000 is substantially equivalent to current and legally marketed devices. Examples are enclosed and include the Richard Wolf Model 5141(K944821), Model 5135 (K944607), the Karl Storz Model 201315-20 (K954561) and the Linvatec Model 8430 (enclosed brochure information). Ea…
Richard Wolf Medical Instruments Corp.1994—
*K944607Model 5135 Auto LP/Flash
Summary page 1
…ce Model LS 6000 is substantially equivalent to current and legally marketed devices. Examples are enclosed and include the Richard Wolf Model 5141(K944821), Model 5135 (K944607), the Karl Storz Model 201315-20 (K954561) and the Linvatec Model 8430 (enclosed brochure information). Each Xenon Light Source…
Richard Wolf Medical Instruments Corp.1994—
*K954561Xenon Noppva
Summary page 1
…nt to current and legally marketed devices. Examples are enclosed and include the Richard Wolf Model 5141(K944821), Model 5135 (K944607), the Karl Storz Model 201315-20 (K954561) and the Linvatec Model 8430 (enclosed brochure information). Each Xenon Light Source is designed the same, meets the same speci…
KARL STORZ Endoscopy-America, Inc.1995—
*—Linvatec Model 8430
Named without a submission number
—

Also cleared against K944821: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K982962Xenon Light Source, Models LS6180, LS6035Contec Medical Vision, Ltd.19980

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K982962 (Contec Medical Vision, Ltd., 1998) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K944821.

How does its category compare?

All GCT devices

GCT Light Source, Endoscope, Xenon Arc: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCT

1in 2010

2007: 12008: 12010: 1
2007high 1 (2007) · low 0 (2009)2026

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

2007: 322008: 292009: 1532010: 212011: 1322012: 362013: 72014: 112015: 82016: 152017: 142018: 202019: 182020: 1142021: 1492022: 1582023: 2002024: 2962025: 347
2007high 347 (2025) · low 7 (2013)2025

MAUDE reports naming product code GCT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—032
20081—029
20090—0153
20101—021
20110—0132
20120—036
20130—07
20140—011
20150—08
20160—015
20170—014
20180—020
20190—018
20200—0114
20210—0149
20220—0158
20230—0200
20240—0296
20250—0347
20260—0—

What is it indicated for?

The Xenon Light Source Model LS6000 is designed

to supply light for endoscopic diagnostic observation

and surgical procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K944821

1 other device cites the same predicate.

  • K982962Xenon Light Source, Models LS6180, LS6035Contec Medical Vision, Ltd. · 1998

More from Contec Medical Vision, Ltd.

2 FDA decisions under this applicant name. See the company

  • K982962Xenon Light Source, Models LS6180, LS6035Contec Medical Vision, Ltd. · 1998

Recent decisions in GCT

The GCT category page

  • K093125Alphaxenon Light 180 W and 300 WGimmi GmbH · 2010
  • K082925Xenon-100 SCB Light Source, Model 20132620KARL STORZ Endoscopy-America, Inc. · 2008
  • K070376Conmed Linvatec 300W Xenon Light SourceConmed Linvatec · 20072 recalls
  • K040949Viaduct Miniscope and AccessoriesAcueity, Inc. · 2004
  • K022490Ksea Medi PackKARL STORZ Endoscopy-America, Inc. · 2003

https://510kreport.com/device/K981804 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981804: Xenon Light Source Model LS6000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981804

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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