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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: HQC FDA class 2

    Unit, Phacofragmentation

    Ophthalmic

    View full classification →

    A Phacofragmentation Unit is an ophthalmic surgical device that uses ultrasonic vibration transmitted through a hollow needle to emulsify and aspirate the crystalline lens during phacoemulsification cataract surgery, allowing lens removal through a small incision. This device is FDA Class 2 (moderate risk), requiring premarket notification (510(k)) before marketing. It carries product code HQC and is regulated under 21 CFR 886.4670, within the Ophthalmic medical specialty. It is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)
    Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)
    Faros Surgical System
    UNITY VCS (8065000296); UNITY CS (8065000297)
    Stellaris Elite vision enhancement system
    Centurion™ Vision System (Active Sentry™) (8065753057)
    QUATERA 700
    MICOR Lens Fragmentation System
    miCOR System Lens Fragmentation System
    EVA NEXUS Ophthalmic Surgical System
    QUATERA 700
    VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control
    xPORT S Lens Fragmentation System
    xPORT 304 (miCOR) System Lens Fragmentation System
    Visalis V500, Visalis S500
    Phacoemulsification Needle (Tip) and Irrigation Sleeve
    LEGION System
    EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)
    COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal
    xPORT Lens Fragmentation System
    Stellaris Elite vision enhancement system
    CENTURION Vision System (Active SentryTM)
    Stellaris Elite Vision Enhancement System
    Dual Pump Pack
    AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control
    COMPACT INTUITIV Multiple-Use Pack
    EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector)
    CATARHEX 3
    STELLARIS PC VISION ENHANCEMENT SYSTEM
    COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK
    STELLARIS VISION ENHANCEMENT SYSTEM
    CENTURION VISION SYSTEM
    LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS
    LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)
    LENSSX LASER SYSTEM
    INFINITI(R) VISION SYSTEM
    SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM
    INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE
    LAMINAR FLOW PHACO TIPS
    AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM
    UNIT, PHACOFRAGMENTATION
    CONSTELLATION VISION SYSTEM
    STELLARIS PC VISION ENHANCEMENT SYSTEM
    AQUALASE CAPSULE WASH TIP
    FLUID ISOLATION DEVICE
    ALCON ULTRACHOPPER
    INFINITI VISION SYSTEM WITH OZIL IP
    ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS
    BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM
    VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551

    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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