510(k) Report

510(k) · Cleared

Cleared

Cogent Light Illuminator 10010 Xenon Light Source

K933405510(k) TraditionalCleared Feb 18, 1994221-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

Cogent Light Technologies, Inc. · GCT Light Source, Endoscope, Xenon Arc

Cleared on Feb 18, 1994 after a 221-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Feb 18, 1994
Review
221 days
Class
Class II
Product code
GCT
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1990200020102020
  1. This deviceK933405 Cogent Light Illuminator 10010 Xenon Light SourceCogent Light Technologies, Inc. · 1994
  2. Descendant · cites it directly · 0 of its ownK970217 Vista Illumination SystemVista Medical Technologies, Inc. · 1997

Most influential descendants

Showing 1 of 1 · See all
  • K970217Vista Illumination SystemVista Medical Technologies, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K933405Cogent Light Illuminator 10010 Xenon Light SourceCogent Light Technologies, Inc.1994—
+1K970217Vista Illumination SystemVista Medical Technologies, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K933405, 1994–1997Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K970217Vista Illumination SystemVista Medical Technologies, Inc.19970

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, K970217 (Vista Medical Technologies, Inc., 1997) has gone furthest, with 0 descendants of its own.

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—

More from Cogent Light Technologies, Inc.

5 FDA decisions under this applicant name. See the company

  • K001698Micro Link Endoscopic Fiber Cable, Model B1-90159Cogent Light Technologies, Inc. · 2000
  • K983714Solartec Source 270, Model # 90123Cogent Light Technologies, Inc. · 1998
  • K971057Cogenlight Technologies XLS Illuminator SystemCogent Light Technologies, Inc. · 1997
  • K936048Lightwear (TM) Syst (Lightwear Headlight Clip/Headband)Cogent Light Technologies, Inc. · 1994

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/K933405 · printed Nov 5, 2026

Cite this page

510(k) Report. “K933405: Cogent Light Illuminator 10010 Xenon Light Source.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K933405

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026