Cleared Abbreviated

K093125 - ALPHAXENON LIGHT 180 W AND 300 W

K093125 is the FDA 510(k) clearance for ALPHAXENON LIGHT 180 W AND 300 W by Gimmi GmbH. It is a Class 2 Gastroenterology & Urology device (product code GCT) cleared through the Abbreviated 510(k) pathway after a 117-day FDA review.

K093125 · Gimmi GmbH · Gastroenterology & Urology device
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Jan 2010
Decision
117d
Days
Class 2
Risk

K093125 is an FDA 510(k) clearance for the ALPHAXENON LIGHT 180 W AND 300 W. Classified as Light Source, Endoscope, Xenon Arc (product code GCT), Class II - Special Controls.

Submitted by Gimmi GmbH (Tuttlingen, DE). The FDA issued a Cleared decision on January 27, 2010 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Gimmi GmbH devices

Submission Details

510(k) Number K093125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2009
Decision Date January 27, 2010
Days to Decision 117 days
Submission Type Abbreviated
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 130d · This submission: 117d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code GCT Light Source, Endoscope, Xenon Arc
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - GCT Light Source, Endoscope, Xenon Arc

All 19
Devices cleared under the same product code (GCT) and FDA review panel - the closest regulatory comparables to K093125.
XENON-100 SCB LIGHT SOURCE, MODEL 20132620
K082925 · KARL STORZ Endoscopy-America, Inc. · Dec 2008
KSEA MEDI PACK
K022490 · KARL STORZ Endoscopy-America, Inc. · Sep 2003
LINVATEC 300W XENON LIGHT SOURCE
K031994 · Linvatec Corp. · Aug 2003
LUMENON XENON LIGHT SOURCE
K992050 · Walter Lorenz Surgical, Inc. · Sep 1999
XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011
K983628 · Richard Wolf Medical Instruments Corp. · Dec 1998
WELCH ALLYN XENON 300 LIGHT SOURCE
K980281 · Welch Allyn, Inc. · Feb 1998