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510(k) Data Aggregation

    K Number
    K252658
    Date Cleared
    2025-11-28

    (98 days)

    Product Code
    Regulation Number
    878.4810
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Medical Diode Laser Systems are intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures. The device's 980nm laser is generally indicated for use in incision, excision, 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 1470nm laser is intended for: Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue-Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux.

    Device Description

    The Medical Diode Laser Systems generate a 980nm wavelength laser to act on a target tissue to achieve resection, hemostasis, ablation, and coagulation of the target tissue.

    The Medical Diode Laser Systems generate 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 Medical Laser Family has following characteristics:

    • Dual wavelengths
    • Temperature monitoring system
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    K Number
    K252564
    Date Cleared
    2025-11-07

    (85 days)

    Product Code
    Regulation Number
    878.4810
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The "VeinCure" is indicated for use in the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

    Device Description

    Diode laser is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source.The diode laser for this unit is GaAlAs (Gallium-aluminum-arsenic) diode bar, and the wavelength is 1470nm. It features impact structure, high efficiency and long lifetime. Generally the beam shall be shamed as the big beam divergence of the laser from the diode. When the coaxiality of laser and fiber meet the requirements, the laser beam can be coupled efficiently into the fiber.

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