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510(k) Data Aggregation

    K Number
    K023249
    Device Name
    ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
    Manufacturer
    ALCON LABORATORIES, INC.
    Date Cleared
    2002-10-18

    (18 days)

    Product Code
    NCF
    Regulation Number
    886.1760
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LADARWave" CustomCornea® Wavefront System is used for measuring, recording, and analyzing visual aberrations (such as myopia, hyperopia, astigmatism, coma and spherical aberration) and for displaying refractive error maps of the eye to assist in prescribing refractive corrections. This device is enabled to export wavefront data and associated anatomical registration information to a compatible treatment laser with an indication for wavefront-guided refractive surgery.
    Device Description
    The LADARWave" CustomCornea® Wavefront System is an aberrometer, utilizing Hartmann-Shack wavefront sensing to measure the aberrations in the human eye. The device contains four major optical subsystems used in the clinical wavefront examination: a fixation subsystem, a video subsystem, a probe beam subsystem, and a wavefront detection subsystem. These subsystems are all under control of the device software.
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