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510(k) Data Aggregation

    K Number
    K192350
    Device Name
    Medical Non-Ablative Fractional Laser Systems
    Manufacturer
    Wingderm Electro-Optics Ltd.
    Date Cleared
    2020-04-30

    (245 days)

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

    Wingderm Electro-Optics Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medical Non-ablative Fractional Laser Systems (Model: WFB-01) is intended for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.
    Device Description
    The Medical Non-ablative Fractional Laser Systems (Model: WFB-01) is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue. The Medical Non-ablative Fractional Laser Systems (Model: WFB-01) includes three main parts, Main Console, Connector and Scan Handpiece. The main console is used for system control, such as control of user interface, power on/off and other functions, and also used as holder for other components. The Connector is used to connect with accessories or power supplier, such as foot switch, pipeline holder, cold air device etc. The Scan Handpiece is used to provide laser emission and graphic scanning functions. It provides three scan heads (AccuTip, EffiTip, GrowTip) for treatment areas.
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    K Number
    K191611
    Device Name
    Diode Laser Therapy Systems
    Manufacturer
    Wingderm Electro-Optics Ltd.
    Date Cleared
    2019-07-31

    (44 days)

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

    Wingderm Electro-Optics Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diode Laser Therapy Systems are intended for hair reduction on all skin types (Fitzpatrick skin type I-VI). Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
    Device Description
    The Diode Laser Therapy Systems has one model WLA-01, which mainly consist of the main console, treatment hand piece and a foot switch. The treat hand piece consist of the laser aperture, laser emission indicator, laser emission and hand piece display screen. The main console consist of power switch, hand piece holder, LCD touch screen, emergency shut off, hand-grip grab bar, connector hand piece, access door, observation Window, power input, inlet, air switch, gate interlock connector, foot switch connector, vent, drain and fans. The device has an embedded software named Diode Laser Therapy Systems Control Software. The principle of laser hair removal is selective photothermolysis, 808nm wavelength effectively penetrates deep into and absorbed by the target chromophore. The adequate pulse duration, energy density and epidermal cooling ensure an adequate thermal damage to the target tissue without damaging the surrounding tissue to achieve effective hair removal. The laser window of the hand piece will contact the skin directly and the laser output will contact the skin through the window. The Diode Laser Therapy System is suitable for use in healthcare facility/hospital.
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