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510(k) Data Aggregation

    K Number
    K100590
    Device Name
    EDGE CO2 LASER SYSTEM
    Manufacturer
    JM SYSTEM CO., LTD.
    Date Cleared
    2010-11-10

    (253 days)

    Product Code
    ONG
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    JM SYSTEM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Edge CO 2 laser when used in traditional non-fractionated scanner mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues. The Edge CO 2 laser when used in fractionated mode is indicated for ablative skin resurfacing.
    Device Description
    The Edge CO2 laser has a wavelength of 10,600nm. CO2 fractional laser uses scanning optics to deliver a pattern of thermal energy to the epidermis and upper dermis. Device accessories include tip attachments. This system consists of main body, color touch screen, Arm, hand-piece and Foot switch.
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    K Number
    K100098
    Device Name
    PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICE
    Manufacturer
    JM SYSTEM CO., LTD.
    Date Cleared
    2010-08-13

    (212 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    JM SYSTEM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PlasmaLipo / Plasma D30 Laser Surgical Device is used for delivery of laser light to soft tissue in the contact mode during surgical procedures, including via catheters. The PlamsaLipo / Plasma D30 is generally indicated for incision, excision, vaporizetion, ablation, hemostasis, or coagulation of soft tissue, particularly for laser assisted lipolysis.
    Device Description
    PlasmaLipo / Plasma D30 Laser Surgical Device
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