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510(k) Data Aggregation

    K Number
    K161727
    Device Name
    Eyenez Ophthalmic Camera
    Manufacturer
    Date Cleared
    2016-10-04

    (104 days)

    Product Code
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    EYENEZ LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Eyenez V200 fundus camera is intended to be used to capture images of the retina of the eye.
    Device Description
    The Eyenez Ophthalmic Camera is a handheld ophthalmic camera that combines a condensing lens with a built-in digital camera to capture a digital photograph of the retina and allow for the examination of the picture by an ophthalmic specialist. The Eyenez Ophthalmic Camera will allow users to capture images of the retina. Images may be saved to a flash memory card and also have connectivity towards PC using a USB interface. Device has a rechargeable battery.
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