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510(k) Data Aggregation

    K Number
    K042083
    Device Name
    MODIFICATION TO VISITOME 20-10 MICROKERATOME
    Manufacturer
    BIOVISION AG
    Date Cleared
    2004-11-16

    (105 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOVISION AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VISITOME 20-10 MICROKERATOME is intended for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.
    Device Description
    The Visitome 20-10 Microkeratome is an AC-powered device that is used for making a flap by incising the cornea at a predetermined thickness and diameter using a high-speed oscillating blade made of stainless steel. The device consists of the following main components and accessories: the control unit, a surgical unit (handpiece with drive assembly, positioning ring assembly, applanator assembly, and a stainless steel blade holder), a foot pedal, and tubing kit with filter and fluid collection container (accessory).
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    K Number
    K014000
    Device Name
    VISTITOME 20-10 MICROKERATOME
    Manufacturer
    BIOVISION AG
    Date Cleared
    2002-03-11

    (97 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOVISION AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Visitome 20-10 Microkeratome is intended for use in the making of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
    Device Description
    The Visitome 20-10 Microkeratome is an AC-powered device that is used for making a flap by incising the cornea at a predetermined thickness and diameter using a high-speed oscillating blade made of stainless steel. The device consists of the following main components and accessories: the control unit, a surgical unit (handpiece with drive assembly, positioning ring assembly, applanator assembly, and a stainless steel blade holder), a foot pedal, tubing kit (accessory), and a fluid collection container (accessory). The Visitome 20-10 Microkeratome contains a positioning ring which allows the cornea to protrude through the ring. The cornea is restrained by an applanation shoe surface, which may be pivoted away. A stainless steel blade is suspended from the end of the positioning ring by a blade support (holder) which is driven by a drive mechanism, so that the blade moves along a forward path between the positioning ring and the applanation shoe while oscillating laterally. Drive control and vacuum for the positioning ring are provided by user command via the control unit and foot pedal.
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