BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    MICRORUPTER V

    K Number: K023045 · Decision Sep 26, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    3
    Same Product Code
    5
    Applicant Total
    6
    Review Days
    14

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    Basic Information

    Device Name
    MICRORUPTER V
    K Number
    K023045
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4392
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Meridian AG
    Date Received
    September 12, 2002
    Decision Date
    September 26, 2002
    Product Code
    LXS
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    Y

    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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