510(k) Report

510(k) · Cleared

Cleared

Xenon Light Source, Models LS6180, LS6035

K982962510(k) TraditionalCleared Sep 23, 199830-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 Sep 23, 1998 as substantially equivalent to K944821 (Richard Wolf Medical Instruments Corp., 1994) and 3 other predicates after a 30-day review. Its family tree reaches back 2 generations to 1994.

Decided
Sep 23, 1998
Review
30 days
Class
Class II
Product code
GCT
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K944821 (1994). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 1 other ancestor1994: 1 other ancestorK944821 · MODEL 5151 · Richard Wolf Medical Instruments Corp. · 1994K981804 · Xenon Light Source Model LS6000 · Contec Medical Vision, Ltd. · 1998199019921994199619982000
Other ancestors, by generation 1 generation back: 2 other ancestors K981804 · Xenon Light Source Model LS6000 · Contec Medical Vision, Ltd. · 1998K944821 · MODEL 5151 · Richard Wolf Medical Instruments Corp. · 19940
  1. Root · 2 generations backK944821 MODEL 5151Richard Wolf Medical Instruments Corp. · 1994
  2. 1 generation backK981804 Xenon Light Source Model LS6000Contec Medical Vision, Ltd. · 1998
  3. This deviceK982962 Xenon Light Source, Models LS6180, LS6035Contec Medical Vision, Ltd. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K944821MODEL 5151Richard Wolf Medical Instruments Corp.1994—
−1K981804Xenon Light Source Model LS6000Contec Medical Vision, Ltd.1998—
0 (this device)K982962Xenon Light Source, Models LS6180, LS6035Contec Medical Vision, Ltd.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510
FIG. 1 — Lineage of K982962, 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.

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
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What was it cleared against? (5)

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
…Xenon Light Source Model LS 6035/6180 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), the Linvatec Model 8430 (enclosed brochure information) and the…
Richard Wolf Medical Instruments Corp.1994—
*K944607Model 5135 Auto LP/Flash
Summary page 1
…del LS 6035/6180 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), the Linvatec Model 8430 (enclosed brochure information) and the CONTEC Model LS6000 (…
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), the Linvatec Model 8430 (enclosed brochure information) and the CONTEC Model LS6000 (K981804). Each Xenon Light Source is desi…
KARL STORZ Endoscopy-America, Inc.1995—
*K981804Xenon Light Source Model LS6000
Summary page 1
…Model 5141(K944821), Model 5135 (K944607), the Karl Storz Model 201315-20 (K954561), the Linvatec Model 8430 (enclosed brochure information) and the CONTEC Model LS6000 (K981804). Each Xenon Light Source is designed the same, meets the same specifications and its indication is the same. The only differenc…
Contec Medical Vision, Ltd.1998—
*—Linvatec Model 8430
Named without a submission number
—

Also cleared against K944821: 1 other device →

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 4 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
  • None of the 4 ancestors has a recall.
  • 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 LS6035 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.

  • K981804Xenon Light Source Model LS6000Contec Medical Vision, Ltd. · 1998

More from Contec Medical Vision, Ltd.

2 FDA decisions under this applicant name. See the company

  • K981804Xenon Light Source Model LS6000Contec 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/K982962 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982962: Xenon Light Source, Models LS6180, LS6035.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982962

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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