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    K Number
    K202989
    Device Name
    Myopia Master
    Manufacturer
    OCULUS Optikgeräte GmbH
    Date Cleared
    2021-07-14

    (287 days)

    Product Code
    MXK, HJO
    Regulation Number
    886.1850
    Why did this record match?
    Applicant Name (Manufacturer) :

    OCULUS Optikgeräte GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Myopia Master is an interferometer indicated for measuring the axial length of the eye and is intended as an aid to eye care providers.
    Device Description
    The OCULUS Myopia Master integrates the axial length measurement function of the cleared OCULUS Pentacam AXL (K152311) into the cleared PARK 1 device (K073508), which is an ocular device that includes Scheimpflug imaging, autorefractometry and keratometry functionalities. The Myopia Master combines the following measuring functions in one unit: Axial length, Auto-Refractometer, Keratometer.
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