510(k) · Cleared

Cleared

Alphaxenon Light 180 W and 300 W

K093125510(k) AbbreviatedCleared Jan 27, 2010117-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

Gimmi GmbH · GCT Light Source, Endoscope, Xenon Arc

Cleared on Jan 27, 2010 as substantially equivalent to K031994 (Linvatec Corp., 2003) and 2 other predicates after a 117-day review. Its family tree reaches back 2 generations to 1996.

Decided: Jan 27, 2010
Review: 117 days
Class: Class II
Product code: GCT
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K962595 (1996). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK962595 Karl Storz Xenon 300 Light Source for Non-Flash ApplicationsKARL STORZ Endoscopy-America, Inc. · 1996
1 generation backK031994 Linvatec 300W Xenon Light SourceLinvatec Corp. · 2003 · Recalled
This deviceK093125 Alphaxenon Light 180 W and 300 WGimmi GmbH · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K962595	Karl Storz Xenon 300 Light Source for Non-Flash Applications	KARL STORZ Endoscopy-America, Inc.	1996	—
−1	K031994	Linvatec 300W Xenon Light Source	Linvatec Corp.	2003	1
0 (this device)	K093125	Alphaxenon Light 180 W and 300 W	Gimmi GmbH	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

FIG. 1 — Lineage of K093125, 1996–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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? (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	Applicant	Decided	Recalls
*	K031994	Linvatec 300W Xenon Light Source Summary page 1 …ber: 876.1500 Proposed Class: II Product Code: GCT D. Pedicate/Legally Market Devices Linvatec 300 W Xenon Light Source (k031994) Karl Storz Xenon Light 300 W (k962595) World of Medicine Lemke GmbH Model XL300IL5 (k021717)…	Linvatec Corp.	2003	1
*	K962595	Karl Storz Xenon 300 Light Source for Non-Flash Applications Summary page 1 …II Product Code: GCT D. Pedicate/Legally Market Devices Linvatec 300 W Xenon Light Source (k031994) Karl Storz Xenon Light 300 W (k962595) World of Medicine Lemke GmbH Model XL300IL5 (k021717) I of 2 === Pag…	KARL STORZ Endoscopy-America, Inc.	1996	—
*	K021717	Endoscopic Light Source, Model XL300/L5 Summary page 1 …y Market Devices Linvatec 300 W Xenon Light Source (k031994) Karl Storz Xenon Light 300 W (k962595) World of Medicine Lemke GmbH Model XL300IL5 (k021717) I of 2 E. Device Description AlphaXenon Light i…	World of Medicine Lemke GmbH	2002	—

Also cleared against K031994: 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 14 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
1 of the 3 ancestors has a recall of any class.
1 other device also cites its predicate K031994.

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. 2010, this device’s year, is highlighted.

FDA decisions per year · GCT

1in 2010

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

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

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	32
2008	1	—	29
2009	0	—	153
2010	1	—	21
2011	0	—	132
2012	0	—	36
2013	0	—	7
2014	0	—	11
2015	0	—	8
2016	0	—	15
2017	0	—	14
2018	0	—	20
2019	0	—	18
2020	0	—	114
2021	0	—	149
2022	0	—	158
2023	0	—	200
2024	0	—	296
2025	0	—	347
2026	0	—	—

What is it indicated for?

AlphaXenon Light 300W and 180W light source is used with an endoscope to provide illumination during endoscopic procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K093125 · printed Nov 5, 2026

Cite this page

510(k) Report. “K093125: Alphaxenon Light 180 W and 300 W.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093125

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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