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510(k) Data Aggregation

    K Number
    K141046
    Device Name
    MIDI-SRS
    Manufacturer
    Date Cleared
    2014-12-24

    (245 days)

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

    SRMC CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MiDi-SRS is intended for use in dermatological procedures requiring the coagulation of soft tissue.
    Device Description
    MiDi-SRS is designed to provide laser energy (1550nm) for use in a variety of dermatology and general surgery procedures. The product consists of main body, a tablet PC, a foot switch, an interlock switch and a key switch. The device fires a 1550nm Er- glass Fiber laser beam which is then split into a number of microscopic beams, producing tiny dot, or pixel-like treatment zones within the selected target area of the skin, leaving the other zones within it perfectly intact.
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