Cleared Traditional

K952028 - COLD LIGHT SOURCE LOS XL-A 100

K952028 is an FDA 510(k) clearance for COLD LIGHT SOURCE LOS XL-A 100, manufactured by Laser Optik Systeme GmbH & Co. KG. The device is a Class 2 Gastroenterology & Urology device with product code GCT cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K952028 · Laser Optik Systeme GmbH & Co. KG · Gastroenterology & Urology device
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Jul 1995
Decision
87d
Days
Class 2
Risk

K952028 is an FDA 510(k) clearance for the COLD LIGHT SOURCE LOS XL-A 100. Classified as Light Source, Endoscope, Xenon Arc (product code GCT), Class II - Special Controls.

Submitted by Laser Optik Systeme GmbH & Co. KG (Mainz, DE). The FDA issued a Cleared decision on July 27, 1995 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Laser Optik Systeme GmbH & Co. KG devices

FDA 510(k) Submission Details - K952028

510(k) Number K952028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1995
Decision Date July 27, 1995
Days to Decision 87 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 130d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCT Device Classification - Class 2, Special Controls

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 21
Devices cleared under the same product code (GCT) and FDA review panel - the closest regulatory comparables to K952028.
WELCH ALLYN XENON 300 LIGHT SOURCE
K980281 · Welch Allyn, Inc. · Feb 1998
ENDOBEAM
K963044 · Corin USA · Sep 1996
XENON NOPPVA
K954561 · KARL STORZ Endoscopy-America, Inc. · Oct 1995
XENON LIGHT SOURCE MODEL 5121
K952696 · Richard Wolf Medical Instruments Corp. · Jul 1995
MODEL 5135 AUTO LP/FLASH
K944607 · Richard Wolf Medical Instruments Corp. · Dec 1994
MODEL 5151
K944821 · Richard Wolf Medical Instruments Corp. · Nov 1994