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510(k) Data Aggregation

    K Number
    K241951
    Device Name
    Lasya-Trinity
    Manufacturer
    Bluecore Company Co., Ltd.
    Date Cleared
    2024-10-10

    (99 days)

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

    Bluecore Company Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lasya-Trinity diode laser system is intended for use in dermatology procedures requiring coagulation with the following indications: The trinity applicator is indicated for benign vascular and vascular dependent lesions. The 808 applicator is indicated for permanent reduction in hair regrowth. Use on all skin types (Fitzpatric I-VI), including tanned skin.
    Device Description
    The Subject device, Trinity-Lasya is a diode laser instrument that use diode as a medium to emit a laser beam of 755 & 808 & 1064nm wavelength. There are two handpiece, the user can choose from. Moreover, a specific software controls the device functions and allows the user selections through the touchscreen display. the system is intended to be used in user facilities such as hospitals, physicians' offices and medical spas, and its major components are the main console unit, foot switch, and individual modules. The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling. Lasya-Trinity Laser System consists of: - System console (contains the system software, power supply, and various other electronic ● and mechanical parts) - . Operator control panel with touch-screen technology (GUI) - Trinity applicator(handpiece) with 1064 nm, 808nm and 755 nm wavelengths applied simultaneously - . 808 applicator(handpiece) with 808nm wavelength - . Footswitch and etc.
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