BEUDAMED
    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: HJO FDA class 2

    Biomicroscope, Slit-Lamp, Ac-Powered

    Ophthalmic

    View full classification →

    The AC-Powered Slit-Lamp Biomicroscope is a diagnostic ophthalmic instrument combining a high-intensity slit light source with a binocular microscope, allowing detailed examination of the anterior and posterior segments of the eye including the cornea, lens, and retina. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance demonstrating substantial equivalence to a predicate device. The product code is HJO, regulated under 21 CFR 886.1850, within the Ophthalmic medical specialty. This device is eligible for third-party 510(k) review by an FDA-accredited reviewer.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    HP-OCT (HP-OCT)
    Kowa SL-19
    MiiS Horus Eye Anterior Camera
    Sunkingdom Slit Lamp
    IOLMaster 700
    SLM-1ER, SLM-2ER, SLM-3ER
    Digital Eye Anterior Camera
    Portable Slit Lamp Microscope
    SL 220
    SLIT LAMP SL-2000
    Marco Ultra M3, Marco Ultra M4
    IOLMaster 700
    VISULUX
    SLIT LAMP, Model: YF-100
    Slit Lamp SL-D301
    ALADDIN HW3.0
    Portable Slit Lamp
    Z5 Slit lamp microscope, Z2 Slit lamp microscope
    Slit Lamp Microscope
    Keeler Slit Lamp
    IOLMaster700
    XCEL 455 SLIT LAMP
    ZEISS CATARACT SUITE MARKERLESS
    SLIT LAMP SL-D701
    KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION)
    DISCOVERY SYSTEM
    OPTICAL BIOMETER AL-SCAN
    ALADDIN
    YZ3 PORTABLE SLIT LAMP
    KOWA SL-17
    SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION
    KEELER SLIT LAMP H-SERIES
    IOLMASTER 500
    RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION
    SLIT LAMP SL-2G
    IOLMASTER 500
    MEDIWORKS SLIT LAMP
    SLIT LAMP BO 900, BQ 900, BP900
    PSL CLASSIC SLIT LAMP
    ATLANTIS SLIT LAMP
    LED LAMP OR OTHER
    SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500
    LENSTAR, MODEL LS900
    GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72
    APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES
    CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATION SERIES)
    SLIT LAMP
    ELLEX SLIT LAMP, MODEL 30XL
    XCEL 255 SLIT LAMP
    KOWA SL-15

    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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