BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP

    K Number: K895864 · Decision Dec 29, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    3
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    87

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    Basic Information

    Device Name
    MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP
    K Number
    K895864
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4392
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Lasag AG
    Date Received
    October 3, 1989
    Decision Date
    December 29, 1989
    Product Code
    LXS
    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
    LXS Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

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