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510(k) Data Aggregation

    K Number
    K141638
    Device Name
    PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE
    Manufacturer
    PROPPER MANUFACTURING CO.,INC.
    Date Cleared
    2014-09-17

    (90 days)

    Product Code
    HLI
    Regulation Number
    886.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROPPER MANUFACTURING CO.,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Propper Insight™ Binocular Indirect Ophthalmoscope is an AC-adapter powered or rechargeable battery powered device for medical professionals containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye
    Device Description
    The Propper Insight™ Binocular Indirect Ophthalmoscope is an AC-powered or rechargeable battery-powered indirect ophthalmoscope that complies with standard ISO 10943:2012, Ophthalmic Instruments - Indirect Ophthalmoscopes. The Propper Insight 100 is a Binocular Indirect Ophthalmoscope (abbreviated - BIO), worn on the medical professional's head containing illumination and viewing optics intended to examine the media and the retina of the eye when used in conjunction with an ophthalmic lens. The illumination part of the Propper Insight™ Binocular Indirect Ophthalmoscope consists of a LED (Light Emitting Diode) source, lenses, a selection of red-free, amber and cobalt blue filters, three sizes of light apertures, diffuser and illumination mirror. The device has optomechanical system for adjustment of illumination level, which is based on the relative positions of two polarizer filters. The viewing part consists of viewing lenses, and mirrors that are adjustable to obtain views of the patient eye fundus. The illumination part and the viewing part are combined in the metal housing (BIO Module) which is attached to the headband with the pivot bracket mechanism. The attachment mechanism allows the BIO Module to be pivoted between in-use (down) and out-of-use positions (up). The attachment mechanism also allows adjustment of the BIO Module relative to the user's eyes for the most optimal viewing path. The attachment mechanism includes a magnetic securement of the BIO Module in both in-use and out-of-use positions. Part of the magnetic securement operates an electric contact to automatically provide power to the illumination source in the in-use position. The BIO Module and the power cable connector (AC-powered version), or the BIO Module and the rechargeable battery are attached to the adjustable headband.
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