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510(k) Data Aggregation

    K Number
    K033949
    Device Name
    VARILUX VISIONPRINT SYSTEM (VPS)
    Manufacturer
    ESSILOR INTL.
    Date Cleared
    2004-07-02

    (196 days)

    Product Code
    HLL
    Regulation Number
    886.1510
    Why did this record match?
    Applicant Name (Manufacturer) :

    ESSILOR INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VPS is a non-invasive ultrasonic device intended to measure the pattern of eye and head movement when viewing lateral visual stimulus, to use as a guide for prescribing progressive power eyeglass lenses.
    Device Description
    The VPS is a non-invasive ultrasonic device intended to measure the pattern of eye and head movement when viewing lateral LED fixation lamps. It consists of a headset and a main body with an ultrasonic transmitter. Two ultrasonic receivers are imbedded in the center nosepiece of the headset. The patient wears the headset and looks at three orange LED fixation lamps in the main body as they light up in succession. As the patient follows the lights from side to side, the device measures the degree of head movement from the center light against a target angle of 40° and a standard deviation. Eye movement is extrapolated to fill the remaining vision angle. The calculated ratio of head/eye movement is used to determine the shape of the peripheral and central fields of the progressive spectacle lenses.
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    K Number
    K003170
    Device Name
    RYTHMIC AND RYTHMIC UV
    Manufacturer
    ESSILOR INTL.
    Date Cleared
    2000-12-15

    (66 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    ESSILOR INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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