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510(k) Data Aggregation

    K Number
    K991124
    Device Name
    VISIJET HYDROKERATOME, MODEL 50
    Manufacturer
    Date Cleared
    2000-10-20

    (567 days)

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

    VISIJET, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VisiJet Hydrokeratome is intended for use in performing anterior lamellar circular corneal resections. The VisiJet Hydrokeratome is indicated for use in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea.
    Device Description
    The VisiJet Hydrokeratome - Model 50 is a non-oscillating, non-mechanical microkeratome which utilizes a continuous high-velocity beam of sterile water for injection to effect a lamellar resection of the cornea. The major elements of this microkeratome are a system console, a footswitch and a handpiece with interchangeable suction rings. The operating principle of the water beam microkeratome is based on the ability to create high levels of static hydraulic pressure that is directed across the cornea, effecting a lamellar resection.
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