BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    LIPOCONTROL

    K Number: K090754 · Decision Jan 21, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    672

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    Basic Information

    Device Name
    LIPOCONTROL
    K Number
    K090754
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osyris Medical
    Date Received
    March 20, 2009
    Decision Date
    January 21, 2011
    Product Code
    ORK
    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
    ORK Laser Assisted Lipolysis