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

    ERCHONIA ML SCANNER (MLS)

    K Number: DEN090008 · Decision Aug 24, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    32
    Applicant Total
    1
    Review Days
    596

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    Basic Information

    Device Name
    ERCHONIA ML SCANNER (MLS)
    K Number
    DEN090008
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    878.5400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Erchonia Medical
    Date Received
    January 5, 2009
    Decision Date
    August 24, 2010
    Product Code
    OLI
    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
    OLI Fat Reducing Low Level Laser

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