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510(k) Data Aggregation

    K Number
    K050856
    Device Name
    LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM
    Manufacturer
    OPHTHOCARE LTD.
    Date Cleared
    2005-05-31

    (56 days)

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

    OPHTHOCARE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LCG (Liquid Crystal Glasses) System is an electronic shutter module intended to provide occlusions of the eye in an intermittent fashion.
    Device Description
    The LCG System comprises the following main components: The Spectacles Unit (LCGU) comprised of the refractive optical lens, Liquid Crystal Module (LCM) and the electronic control that resides in the holding strap. The adjustable holding strap contains an electronic controller with an activation button (Tact Switch) and small rechargeable batteries that provide the electric power. The Reporting and Compliance Box (RCB) is a bedside device that serves as a charger of the spectacle's batteries. In addition, it provides a means to monitor the compliance of the patient, while providing a feedback to the user, as it records the actual wear-time of the glasses, comparing it to the prescribed time. Technician/Factory Setup Software (LCG Set) is software residing on a PC at the factory and is used for setting the LCGU performance parameters. During setup, the LCGU is connected to the PC via the RCB by means of RS232 link.
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