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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: MSS FDA class 1

    Folders And Injectors, Intraocular Lens (Iol)

    Ophthalmic

    View full classification →

    Intraocular Lens (IOL) Folders and Injectors are surgical instruments used to fold and insert foldable intraocular lenses into the eye during cataract surgery, enabling minimally invasive lens delivery through a small incision. They are classified as FDA Class 1, subject to general controls only, with product code MSS under 21 CFR 886.4300 in the Ophthalmic specialty. No premarket notification is required. These devices are not implants themselves and are not life-sustaining.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    EyeGility™ Inserter for Preloaded enVista IOLs
    Accuject Refra Injector AR2900
    RxSight® Insertion Device (63002)
    RxSight Insertion Device
    CLAREON MONARCH IV IOL Delivery System
    bioli lOL Delivery System
    RxSight Insertion Device
    Bausch + Lomb PreVue Inserter for enVista Preloaded
    UNFOLDER Vitan Inserter
    BL-Cart IOL Delivery Cartridge
    RxSight Insertion Device
    pioli IOL Delivery System
    Crystalsert Lens Delivery System
    MicroSTAAR Injector System Cartridges
    Lenstec LC Injection system
    Easy-Load Lens Delivery System
    Bausch + Lomb Injector System
    One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series
    LIOLI IOL DELIVERY SYSTEM
    RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector
    RAYSERT PLUS INJECTOR
    SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR
    BAUSCH & LOMB INJECTOR SYSTEM
    BAUSCH + LUMB, VIS100 INJECTOR SYSTEM
    EASY-LOAD LENS DELIVERY SYSTEM
    LENSTEC LC INJECTION SYSTEM
    CRYSTALSERT DELIVERY SYSTEM
    CRYSTALSERT DELIVERY SYSTEM
    Z CARTRIDGE IOL DELIVERY SYSTEM
    BAUSCH & LOMB IOL INJECTOR
    MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)
    MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)
    ASICO SOFTIP INJECTOR SYSTEM
    MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE
    VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430
    RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18
    NAVIJECT SUB2-1P, MODEL: LP604430
    XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM
    EPIPHANY INJECTION SYSTEM
    HOYA IS INJECTOR SYSTEM
    CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
    ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30
    RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06
    MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM
    MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM
    ROYALE AE 9036 LSP INJECTOR
    LENSTEC LC INJECTION SYSTEM
    RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04
    DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788
    LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM

    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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