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    K Number
    K132042
    Device Name
    AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND
    Manufacturer
    X6D, LTD.
    Date Cleared
    2014-04-28

    (300 days)

    Product Code
    HOY
    Regulation Number
    886.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    X6D, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Amblyz™ System is an electronic shutter module intended to provide occlusions of the eye in an intermittent fashion.
    Device Description
    The Amblyz™ device is an optical eyewear using a Liquid Crystal lens and electronics technology that acts as an intermittent shutter. The shutter incorporated in the optical lens performs an occlusion of the sound eye in an intermittent mode by changing the lens from a clear to an opaque state via electronic control. The system incorporates the following components: Spectacle Frame, Liquid Crystal Shutter (LCS), Earpieces, Nose Piece, Clip to Hold Refractive Lens, Micro-USB Connector, LED Indicator, ON/OFF Switch, Programming Button, Amblyz™ onboard Software, Amblyz™ Technician Software.
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