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510(k) Data Aggregation

    K Number
    K071755
    Device Name
    FALCK APPLANATION TONOMETER (FAT2)
    Manufacturer
    Date Cleared
    2008-06-03

    (341 days)

    Product Code
    Regulation Number
    886.1930
    Why did this record match?
    Applicant Name (Manufacturer) :

    FALCK MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Falck Medical Applanation Tonometer Model 2 (FAT 2) is indicated in the measurement of intraocular pressure and ocular pulsatile amplitude.
    Device Description
    The Falck Medical Applanation Tonometer (FAT 2) measures the intraocular pressure by applanation of the cornea uses a disposable sterile plastic prism. It is used as an accessory to a slit lamp microscope. Internal software is used for error checking and calibration. The disposable prism is mounted on a free floating counterweighted arm. When the prism comes into contact with the cornea, the initial applanation area is determined by the biomechanics of the cornea. Force is then actively applied to the cornea and measurements are taken every 13.8 milliseconds. Multiple readings are taken and statistical analysis is performed to ensure repeatability. The measurement principle is the same as the Goldmann, but adjustments are reade for variations in surface wetness and corneal resistance. The size of the applanation area is objectively determined by using visible light and the principle of total internal reflectance (TIR). A new sterile disposable prism is required prior to each new patient. In addition to intraocular pressure, the device also measures ocular pulsatile amplitude by recording the change in the applanation signal that occurs with the cardiac cycle. The measurement of ocular pulsatile amplitude is similar to the Langham methodology.
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