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510(k) Data Aggregation

    K Number
    K043503
    Device Name
    VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1
    Manufacturer
    VISX, INCORPORATED
    Date Cleared
    2005-04-05

    (106 days)

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

    VISX, INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VISX CV SI-1 CustomVue Slit Illuminator is a diagnostic illumination device intended for use to inspect the structures of the anterior segment of the eye.
    Device Description
    The VISX CV SI-1 CustomVue Slit Illuminator consists of the slit illuminator and a charger unit. The charger unit serves both as a continuous charger as well as a convenient base for the instrument. The slit illumination is focused onto the corneal surface, which is observed through the operating microscope (or the surgeon may also alter the angle of the slit illumination). The length and width of the slit may be altered by the surgeon. The slit illuminator allows the control of slit width to enhance observation of structural detail. The slit illuminator allows control of slit width from 0 to 10.0 mm via means of sliding control knobs.
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    K Number
    K000327
    Device Name
    WAVESCAN WAVEFRONT SYSTEM MODEL HS 1
    Manufacturer
    VISX, INCORPORATED
    Date Cleared
    2000-05-02

    (90 days)

    Product Code
    HKO
    Regulation Number
    886.1760
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISX, INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VISX WaveScan™ Wavefront System is a diagnostic instrument indicated for the automated measurement and analysis of refractive errors of the eye including hyperopia and myopia from +6.00 to -8.00 diopters spherical, and astigmatism from 0.00 to -6.00 diopters.
    Device Description
    The WaveScan™ Wavefront System Model HS 1 autorefractor device is a diagnostic instrument designed to measure refractive error of the eye automatically by use of wavefront technology. Light travels in a procession of flat sheets known as wavefronts. As these wavefronts pass through an imperfect refractive medium including the cornea and the lens, the aberrations which are created by the irregular surfaces "wrinkle" the light rays and create wavefront errors or distortions. The instrument contains tiny sensors which measure the gradient, or slope, of the wavefront which emanate from the eye. After light travels through the eye's optical system and out again, the sensors accurately detect slight variations of wavefront irregularities as they exit the eye. The sensors then provide additional information within the confines of the instrument through a series of lenses and apertures which are subject to mathematical algorithms and software. Once analyzed by the computer, a refractive error read-out is provided to the user. This analysis is made from multiple points of light which precisely pinpoint variations in refractive status across the entrance pupil of the eye. This allows for the high level of accuracy of the instrument thus providing the user with very precise readings of refractive error.
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