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

    CELLULAZE LASER

    K Number: K123407 · Decision Mar 29, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    1
    Applicant Total
    98
    Review Days
    144

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    Basic Information

    Device Name
    CELLULAZE LASER
    K Number
    K123407
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cynosure, Inc.
    Date Received
    November 5, 2012
    Decision Date
    March 29, 2013
    Product Code
    OYW
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OYW Laser, Cellulite Appearance

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