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510(k) Data Aggregation

    K Number
    K052674
    Device Name
    CONTACT LENS OPHTHALMODYNAMOMETER
    Manufacturer
    Date Cleared
    2006-05-24

    (239 days)

    Product Code
    Regulation Number
    886.1385
    Why did this record match?
    Product Code :

    NYK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is indicated for examination of the ocular fundus, vitreous and retinal structures, while manually applying force to the eye with the contact lens. The device measures and displays the amount of force that is applied to the eye.
    Device Description
    The Meditron Contact Lens Ophthalmodynamometer is a classic Goldmann three-mirror examination contact glass that has been adapted with precision electronic sensors for continuous measurement of pressure applied to the eye. Electronic signals from the sensors are used to determine pressure values, which are then displayed on the device's LCD display. The patient contact portion of the examination glass consists of a curved shell of acrylic plastic (PMMA) that is applied for a short period of time directly on the globe or cornea of the eye. PMMA is commonly used as a material in examination contact glasses having the same intended purpose. The mirror angles are the same as the original Goldmann and predicate devices: 59/66/73 degrees.
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