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

    WAVELIGHT FS200 LASER SYSTEM

    K Number: K141476 · Decision Sep 30, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    46
    Applicant Total
    1
    Review Days
    118

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    Basic Information

    Device Name
    WAVELIGHT FS200 LASER SYSTEM
    K Number
    K141476
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4390
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alcon Research, Ltd. Dba Alcon Laboratories, Inc.
    Date Received
    June 4, 2014
    Decision Date
    September 30, 2014
    Product Code
    OOE
    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
    OOE Ophthalmic Femtosecond Laser

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