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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: FST FDA class 2

    Light, Surgical, Fiberoptic

    General, Plastic Surgery

    View full classification →

    A fiberoptic surgical light is a lighting system that uses fiber optic cables to transmit light from a remote source to the surgical field or instrument, providing bright, cool illumination. 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 FST, regulated under 21 CFR 878.4580, within the General, Plastic Surgery medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    45 matches
    K Number
    Device Name
    TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End
    ENDO-CORD
    LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999
    EIGR SURGICAL ILLUMINATION SYSTEM
    CABLECAP
    ISOLED AC-POWERED LED HEADLIGHT SYSTEM
    CABLECAP MODEL: WLF, STZ, ACM
    21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS
    HARMONY VLED SURGICAL LIGHTNING SYSTEM
    CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST
    INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM
    RETRACTOR LITE
    AXXION LIGHT GUIDE
    LITE WAND II
    ZIMMER MIS LIGHT
    PROXENON 350, MODEL 902XX
    SURGICAL HEADLIGHT
    LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES
    MELIDE FIBEROPTIC LIGHT
    NUVASIVE MAXCESS LIGHT GUIDE
    STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT
    MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE
    ISOLUX SURGICAL HEADLIGHT
    UFR FIBEROPTIC CABLE
    X6000D SILENT SUN LIGHT SOURCE
    LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND)
    END-IRRIGATING ENDOILLUMINATOR
    WOODBINE XT350, XENON ARC LIGHT SOURCE
    MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE
    NEXTEC FIBEROPTIC ILLUMINATOR 300 WATT XENON
    METAL HALIDE LIGHT SOURCE MODEL LM 250
    INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT
    FIBER OPTIC LIGHT CABLE
    CUDA SURGICAL LIGHT
    FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE
    ML-800 AUTOELECTRONIC LIGHT SOURCE
    MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300
    PRISMA DISPOSA. BRITE LITE FIBEROPTIC ENDO. W/PICK
    PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
    PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK
    PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
    OPHTHALMIC LIGHT PIPE PICK
    MVS FIBEROPTIC LIGHTPIPE
    LUTEX HEADLIGHT SYSTEMS
    HEADLIGHTS W/ FILTER-OPTICO CABLES

    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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