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510(k) Data Aggregation

    K Number
    K252564
    Device Name
    Medical Diode Laser Systems (VeinCure)
    Manufacturer
    Baoding Te'anzhou Electronic Technology Co., Ltd.
    Date Cleared
    2025-11-07

    (85 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K211977
    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.

    AI/ML Overview

    N/A

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