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510(k) Data Aggregation

    K Number
    K133062
    Device Name
    DISCOVERY SYSTEM
    Date Cleared
    2014-06-20

    (266 days)

    Product Code
    Regulation Number
    886.1850
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    Applicant Name (Manufacturer) :

    INNOVATIVE VISUAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Discovery System is intended for use in: -Mapping the lower and higher order aberrations of the eye which includes measurement of the spherical power, cylindrical power and cylinder axis. -The measurement and analysis of corneal curvature (comeal refractive power, and cylinder axis of the cornea. The device also maps the display of the corneal shape. - White-to-white measurements (also called WTW or horizontal corneal diameter). -Retro-illumination imaging of the anterior segment of the eye including intraocular lens imaging. - The measurement of pupil diameter. -In the automated measurement and analysis of refractive errors of the eye including hyperopia and myopia from -25.0 to +15.0 diopters spherical, and astigmatism from 0.0 to ± 10.0 diopters.
    Device Description
    The Discovery System combines a corneal topographer and an ocular wavefront aberrometer into a single, efficient system. The Discovery System combines several features to provide clinicians with detailed ophthalmic measurements. The Discovery System is designed to quickly and easily capture: - Anterior corneal topography . - Ocular wavefront aberrations . - Retro-illumination images . - Iris images . Using near infrared (NIR) light sources for both the corneal topography and ocular wavefront aberrations permits these measurements to be taken simultaneously along the same optical axis. Retro-illuminated imaging is provided using a NIR light source reflected off the retina and optional white light and/or NIR anterior eye light sources. Iris images are captured during a retro-illumination acquisition and can optionally be captured during all other exam type acquisitions to identify eye rotations between examinations.
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