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510(k) Data Aggregation

    K Number
    K031831
    Device Name
    TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
    Manufacturer
    TOPCON MEDICAL SYSTEMS, INC.
    Date Cleared
    2003-12-19

    (189 days)

    Product Code
    HKO, HKN, HOX
    Regulation Number
    886.1760
    Why did this record match?
    Product Code :

    HKO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Topcon Model BV-1000 Automated Subjective Refraction System provides sphere, cylinder, and axis measurements of the eye. The BV-1000 assists the eyecare professional in evaluating pre and post operative eye procedures and is used as an aid in prescribing eyeglasses and contact lenses.
    Device Description
    The Topcon Model BV-1000 is a safe and effective instrument. In essence, it is a combination of three Class I devices: 1) Ophthalmic Refractometer ... an AC-powered device that consist of a fixation system, a measurement and recording system and an alignment system. 2) Visual Acuity Chart ... a device, with a Landolt "C" chart in graduated sizes to test visual acuity 3) Onthalmic Motorized Refractor ... a device that incorporates a set of lenses of various dioptric powers intended to measure the refractive power of the eyc. The BV-1000 is designed to perform binocular, simultaneous auto-refraction. It incorporates subjective refinement steps after the objective measurements have been obtained. The BV-1000 reduces the amount of time that eyecare professionals need to spend in refracting their patients as a substantial portion of the traditional refraction can be accomplished in the "pre test" room.
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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?
    Product Code :

    HKO

    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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