Cleared Traditional

K971057 - COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM

K971057 is an FDA 510(k) clearance for COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR..., manufactured by Cogent Light Technologies, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code GCT cleared through the Traditional 510(k) pathway after a 4-day FDA review.

K971057 · Cogent Light Technologies, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
4d
Days
Class 2
Risk

K971057 is an FDA 510(k) clearance for the COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM. Classified as Light Source, Endoscope, Xenon Arc (product code GCT), Class II - Special Controls.

Submitted by Cogent Light Technologies, Inc. (Valencia, US). The FDA issued a Cleared decision on March 28, 1997 after a review of 4 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 Cogent Light Technologies, Inc. devices

FDA 510(k) Submission Details - K971057

510(k) Number K971057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1997
Decision Date March 28, 1997
Days to Decision 4 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
127d faster than avg
Panel avg: 131d · This submission: 4d
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 29
Devices cleared under the same product code (GCT) and FDA review panel - the closest regulatory comparables to K971057.
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ENDOBEAM
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K962365 · Dsp Worldwide · Jul 1996