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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: GCT FDA class 2

    Light Source, Endoscope, Xenon Arc

    Gastroenterology, Urology

    View full classification →

    The Light Source, Endoscope, Xenon Arc (product code GCT) is a high-intensity xenon arc lamp used as an external light source to illuminate endoscopes, providing bright, white light for clear visualization during gastrointestinal or urological endoscopic procedures. It is classified as FDA Class 2, indicating moderate risk, subject to 510(k) requirements. The device is regulated under 21 CFR 876.1500 in the Gastroenterology, Urology specialty (GU). No special flags apply to this device.

    510(k) Clearances

    47 matches
    K Number
    Device Name
    ALPHAXENON LIGHT 180 W AND 300 W
    XENON-100 SCB LIGHT SOURCE, MODEL 20132620
    CONMED LINVATEC 300W XENON LIGHT SOURCE
    VIADUCT MINISCOPE AND ACCESSORIES
    KSEA MEDI PACK
    LINVATEC 300W XENON LIGHT SOURCE
    ENDOSCOPIC LIGHT SOURCE XL180/L3
    ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5
    ENDOSCOPIC LIGHT SOURCE XL202/L3
    DAYLITE XENON LIGHT SOURCES
    XENON LIGHT SOURCE PES 1
    LUMENON XENON LIGHT SOURCE
    XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011
    XENON LIGHT SOURCE, MODELS LS6180, LS6035
    XENON LIGHT SOURCE MODEL LS6000
    WELCH ALLYN XENON 300 LIGHT SOURCE
    COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM
    WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175
    ENDOBEAM
    XENON LIGHTSOURCE
    XENON NOPPVA
    XLS-300 XENON LIGHT SOURCE
    COLD LIGHT SOURCE LOS XL-A 100
    XENON LIGHT SOURCE MODEL 5121
    THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM
    ACCU-BEAM 300W XENON LIGHT SOURCE
    XENON LIGHT SOURCE
    MODEL 5135 AUTO LP/FLASH
    MODEL 5151
    KARL STORZ XENON LIGHT SOURCE MODEL 201320-20
    LCI-100 AND LCI-200 WELCH ALLYN ILLUMINATION AND IMAGING SYSTEM
    ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES
    COGENT LIGHT ILLUMINATOR 10010 XENON LIGHT SOURCE
    COOL LIGHT 300
    ANGIOLAZ VIDEO ENDOSCOPIC SYSTEM MODEL CAMLUM1 AND ACCESSORIES
    VERRES NEEDLE
    XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300
    PENTAX XENON LIGHT SOURCE
    SYSTEM 3000 XENON VIDEOLAP LIGHT
    XENON LIGHT SOURCE AND ACCESSORIES
    MARLOW VERRES NEEDLES
    OLYMOUS XLS XENON LIGHT SOURCE
    ENDOSCOPIC LIGHT SOURCE
    ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE
    MULTIPLE IMAGING XENON ARC AUTO LIGH SOURCE
    THE KEYMED HI-LIGHT 250 LIGHT SOURCE
    PENTEX UPPER G.I. SCOPE MODEL FG-28A

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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