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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: FSY FDA class 2

    Light, Surgical, Ceiling Mounted

    General, Plastic Surgery

    View full classification →

    A ceiling-mounted surgical light is a fixed overhead lighting system installed in operating rooms to provide hands-free, overhead illumination of the surgical field from an adjustable ceiling mounting point. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FSY, regulated under 21 CFR 878.4580, within the General, Plastic Surgery medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Leo Minor
    CLAVEGUARD FREEDOM SURGICAL LIGHT
    MI-750 PROCEDURAL/MINOR SURGICAL LIGHT
    ZF 720
    VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES
    MACH LED 2SC
    MACH LED 2MC
    VISUM BLADE LED SURGICAL LIGHTING SYSTEM
    VIDA LED SURGICAL LIGHTING SYSTEM
    AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS
    ORICARE L2700
    CHROMOPHARE F 628 AND F 528
    TRULIGHT 5520 AND TRULIGHT 5320
    AIM 200, MAJOR SURGICAL LIGHT
    STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS
    MACH LED MC
    MACH LED SC
    CHROMOPHARE E 668
    NUVO VERDE LED LIGHTING SYSTEM
    CHROMOPHARE E 778 AND E 558
    CHROMOPHARE E-SERIES
    HARMONY LED-1 SURGICAL LIGHTING SYSTEM
    AURORA LED SERIES SURGICAL LIGHTS
    POWERLED SURGICAL LIGHT SYSTEM
    M3
    ILED
    VISUM LED SURGICAL LIGHTING SYSTEM
    OUTPATIENT III MINOR SURGERY LIGHT
    DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD
    ALM X'TEN (X10) SURGICAL LIGHT SYSTEM
    MODIFICATION TO PRISMALIX SURGICAL LIGHT
    STRYKER VISUM SURGICAL LIGHTING SYSTEM
    CONMED INTEGRATED SYSTEMS NURSES ASSISTANT
    AXCEL SURGICAL LIGHT
    CHROMOPHARE X 65
    STELLAR SERIES SURGICAL LIGHTS WITH HERMES
    TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001
    VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB
    STELLAR
    VISIONARY 2000
    CASTLE SURGICAL LIGHT, MODEL 3000
    MILLENNIUM GOLD
    CHROMOPHARE D 530 LDR SURGICAL LIGHT
    CHROMOPHARE D500, D530, D650
    DRAGER SOLA SERIES, MODELS 1000/700/500/300
    ALM PRISMALIX (PRX) SURGICAL LIGHT
    BRIGHTSTAR
    GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT
    CHROMOPHARE D 500, CHROMOPHARE D 530
    HANAULUX BLUE 75 AND HANAULUX BLUE 120

    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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