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510(k) Data Aggregation

    K Number
    K212733
    Device Name
    Diode laser therapy device
    Date Cleared
    2023-06-06

    (645 days)

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

    Beijing Star New Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Diode laser therapy device is intended for delivery of laser light to soft tissue in the contact mode during surgical procedures. The device's 980mm laser is generally indicated for use in incision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device's intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures, indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
    Device Description
    The diode laser generates a 980nm wavelength laser to act on a target tissue to achieve resection, hemostasis, ablation, and coaqulation of the target tissue. The diode laser generates a 1470 nm wavelength laser that acts on the water molecules of the target tissue to achieve the function of treatment of reflux of the saphenous veins associated with varicose veins and varicosities. The Diode laser therapy device has following characteristics: - Dual wavelengths A - A Temperature monitoring system
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