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

    Galilei G6 Lens Professional

    K Number: K182659 · Decision Jul 25, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    303

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    Basic Information

    Device Name
    Galilei G6 Lens Professional
    K Number
    K182659
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sis Ag, Surgical Instrument Systems
    Date Received
    September 25, 2018
    Decision Date
    July 25, 2019
    Product Code
    MXK
    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
    MXK Device, Analysis, Anterior Segment

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