BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    VISIJET HYDROKERATOME, MODEL 50

    K Number: K991124 · Decision Oct 20, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    567

    Basic Information

    Device Name
    VISIJET HYDROKERATOME, MODEL 50
    K Number
    K991124
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4370
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    VISIJET, INC.
    Date Received
    April 2, 1999
    Decision Date
    October 20, 2000
    Product Code
    MYD
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MYD Keratome, Water Jet