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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: OWN FDA class 2

    Confocal Optical Imaging

    Gastroenterology, Urology

    View full classification →

    The Confocal Optical Imaging device is used for the collection of light signals to enable visualization of cellular microstructures, with applications in gastroenterology and urology. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OWN, with regulation number 876.1500 under the Gastroenterology, Urology medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    OPTOVISION Endoscopic Light Source Unit
    Histolog® Scanner (Hardware 2.4, Software 3.3)
    KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit
    KARL STORZ ICG Imaging System
    1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM
    ActivSight Intraoperative Imaging System
    FloNavi Open Field Fluorescence Imaging System
    L12 LED Light Source with AIM
    SmartSurgN Visualization System
    VS3-Iridium System (VS3-IR)
    780 nm L11 LED Light Source with AIM
    Cellvizio 100 series system with confocal Miniprobes
    VS3 Iridium Sytem
    KARL STORZ ICG Imaging System
    Cellvizio I.V.E. system with Confocal Miniprobes
    ActivSight Intraoperative Imaging System
    KARL STORZ ICG Imaging System
    SPY-PHI System with SPY-PHI Fluorescence Assessment Software
    HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head
    Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head
    SPY Portable Handheld Imaging (SPY-PHI) System
    Cellvizio I.V.E. with Confocal Miniprobes
    Cellvizio 100 Series System with Confocal Miniprobes
    VS3-IR
    L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable
    SPY Portable Handheld Imaging (SPY-PHI) System
    L10 LED Light Source with AIM, L11 LED Light Source with AIM
    SPY Portable Handheld Imaging (SPY-PHI) System
    VS3-IR
    Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes
    Stryker AIM Light Source and SafeLight cable
    Cellvizio 100 Series System with Confocal Miniprobes
    Cellvizio 100 Series Systems with Confocal Miniprobes
    KARL STORZ ICG Imaging System
    KARL STORZ ICG Imaging System
    SPY Phi Open Field Handheld Fluorescence Imaging System
    KARL STORZ Endoscopic ICG Imaging System
    CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes
    Cellvizio 100 Series System with Confocal Miniprobes
    VS3-IR system
    Cellvizio 100 Series System with Confocal Miniprobes
    Artemis Hand Held Imaging System
    VS3-IR-MMS System
    Stryker Infrared Fluorescence (IRF) Imaging System
    CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES
    CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM)
    FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM
    CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED
    DA VINCI FLUORESCENCE IMAGING VISION SYSTEM
    CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES

    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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