Cleared Traditional

K935423 - COOL LIGHT 300

K935423 is an FDA 510(k) clearance for COOL LIGHT 300, manufactured by Endosurgical Development Corp.. The device is a Class 2 Gastroenterology & Urology device with product code GCT cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K935423 · Endosurgical Development Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
78d
Days
Class 2
Risk

K935423 is an FDA 510(k) clearance for the COOL LIGHT 300. Classified as Light Source, Endoscope, Xenon Arc (product code GCT), Class II - Special Controls.

Submitted by Endosurgical Development Corp. (Lomita, US). The FDA issued a Cleared decision on January 26, 1994 after a review of 78 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 Endosurgical Development Corp. devices

FDA 510(k) Submission Details - K935423

510(k) Number K935423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1993
Decision Date January 26, 1994
Days to Decision 78 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
52d faster than avg
Panel avg: 130d · This submission: 78d
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 K935423.
KARL STORZ XENON LIGHT SOURCE MODEL 201320-20
K934559 · KARL STORZ Endoscopy-America, Inc. · Apr 1994
LCI-100 AND LCI-200 WELCH ALLYN ILLUMINATION AND IMAGING SYSTEM
K940270 · Welch Allyn, Inc. · Apr 1994
ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES
K936198 · Carl Zeiss, Inc. · Apr 1994
XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300
K924897 · Medical Devices, Inc. · Jul 1993
PENTAX XENON LIGHT SOURCE
K921315 · Pentax Precision Instrument Corp. · Jun 1993
SYSTEM 3000 XENON VIDEOLAP LIGHT
K923210 · Cabot Medical Corp. · Oct 1992