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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: HOY FDA class 1

    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

    Ophthalmic

    View full classification →

    An Ophthalmic Eye Shield (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear) is a protective device worn over one or both eyes to shield them from light, trauma, or contamination following ophthalmic procedures, pharmacological dilation, or exposure to ultraviolet radiation sources such as sunlamps. This device is FDA Class 1 (lowest risk), subject only to general controls without requiring premarket notification. It carries product code HOY and is regulated under 21 CFR 886.4750, within the Ophthalmic medical specialty. It is exempt from Good Manufacturing Practice (GMP) requirements.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND
    LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM
    NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS
    ARCTIC PREMIER SERIES
    GOGGLE SAFEGUARD
    SHIELD, EYE, OPHTHALMIC
    MAKROLON 2405 GOGGLES (LIGHT AND DARK)
    AMCON SLIP IN MYDRIATIC SUNGLASSES
    SUN FILTERS/SHIELDS
    SHAIDS PROTECTIVE GLASSES
    UNIVERSAL CUSHIONED POLYCARBONAT EYE SHIELD
    UNIVERSAL CUSHIONED METAL EYE SHIELD
    POST-MYDS(TM)
    FOX EYE ALUMINUM SHIELD, OPHTHALMIC
    GOGGLE SAFEGUARD
    MODIFICATION OF SURGICAL EYESHIELD MASK
    ACTION MEDTEK/DENTEK EYEGLASSES
    INSTRUMENT WIPE AND CORNEAL SHIELD
    PEEPERS TANNING GOGGLES
    UNIDIRECTIONAL OCCLUDER
    EYE BUBBLE
    OCULAR OCCLUDER
    OMNIPATCH
    SOFT CORNEAL LIGHT SHIELD
    STRAPPED EYE SHIELD
    EYE PATCH
    LID LOC
    SAFE-EDGE EYESHIELD
    UNIVERSAL EYESHIELD
    DIOPTICS EYESHIELDS
    CLEAR EYE GARTER SHIELD
    COOL EYE(TM) EYE PROTECTOR
    ULTRAVIOLET LIGHT PROTECTVE EYEWERE
    BLUE PLASTIC EYE SHIELD
    SURGIN EYE SHIELD
    EASY SHIELD ADHESIVE BANDAGE
    MEDICAL EYE DISPOSABLE SHIELD
    HEALTH CARE EYE PROTECTION
    WINK-EASE PERSONAL PROTECTIVE EYEWEAR
    TAPELESS EYE SHIELD
    EYE GARD
    KASEY EYE SHIELD
    HESSBURG LIGHT GUARD
    LASERSAFE EYE SHIELDS
    SCHWARTZ/NORRIS CORNEAL LIGHT SHIELD
    COLOR OPTIC CORNEAL EYE SHIELD
    CORNEAL LIGHT SHIELD
    COLOR OPTIC CORNEAL EYE SHIELD
    STORZ UNIVERSAL EYE SHIELD
    NEONATE MASK FOR BABIES

    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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