Cleared Traditional

K013880 - DAYLITE XENON LIGHT SOURCES

K013880 is an FDA 510(k) clearance for DAYLITE XENON LIGHT SOURCES, manufactured by Designs For Vision, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code GCT cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K013880 · Designs For Vision, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
14d
Days
Class 2
Risk

K013880 is an FDA 510(k) clearance for the DAYLITE XENON LIGHT SOURCES. Classified as Light Source, Endoscope, Xenon Arc (product code GCT), Class II - Special Controls.

Submitted by Designs For Vision, Inc. (Ronkonkoma, US). The FDA issued a Cleared decision on December 7, 2001 after a review of 14 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 Designs For Vision, Inc. devices

FDA 510(k) Submission Details - K013880

510(k) Number K013880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2001
Decision Date December 07, 2001
Days to Decision 14 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 131d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 30
Devices cleared under the same product code (GCT) and FDA review panel - the closest regulatory comparables to K013880.
CONMED LINVATEC 300W XENON LIGHT SOURCE
K070376 · Conmed Linvatec · Aug 2007
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 PES 1
K992540 · Laser Optik Systeme GmbH & Co. KG · Sep 1999
XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011
K983628 · Richard Wolf Medical Instruments Corp. · Dec 1998