BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    EDGE CO2 LASER SYSTEM

    K Number: K100590 · Decision Nov 10, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    34
    Applicant Total
    2
    Review Days
    253

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    Basic Information

    Device Name
    EDGE CO2 LASER SYSTEM
    K Number
    K100590
    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
    Jm System Co., Ltd.
    Date Received
    March 2, 2010
    Decision Date
    November 10, 2010
    Product Code
    ONG
    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
    ONG Powered Laser Surgical Instrument With MicrobeamFractional Output

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    Other Clearances by Jm System Co., Ltd.

    K Number Device Name
    K100098 PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICE