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510(k) Data Aggregation

    K Number
    K161670
    Device Name
    Lucid Q-PTP / HWA 55
    Manufacturer
    BISON MEDICAL CO., LTD
    Date Cleared
    2016-11-02

    (139 days)

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

    BISON MEDICAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LUCID O-PTP Nd : YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatologic and general surgical procedures for coagulation and hemostasis. 532nm Wavelength (nominal delivered energy of 585 nm with optional dye hand pieces): Tattoo removal light ink (red, tan, purple, orange, sky blue, green), Removal of Epidermal Pigmented Lesions, Minor Vascular Lesions, Talangiectasias Treatment of Lentigines, Cafe-Au-Lait, Sebrorrheic Keratoses, Post Inflammatory Hyper-Pigmentation, Treatment of Becker's Nevi, Freckles and Nevi Spilus 1064nm Wavelength: Tattoo removal: dark ink ( black, blue, brown) Removal of Nevus of Ota Removal or lightening of unwanted hair with or without adjuvant preparation Treatment of Common Nevi, Melasma, Skin resurfacing procedures for the treatment of acne scars, wrinkle
    Device Description
    The LUCID O-PTP O-Switched Nd: Y AG laser system produces a two pulsed beam, 1064 nm Infrared and 532nm long pulse laser, and optional 2 dye Handpieces are available that convert the 532nm wave length to 585nm and 650nm, using different Handpiece able to control various treatment fluence. this device is non-contacted mode and consists of main function, laser tube ; placed in the mixed crystals of copper pipe to the heater and produces a laser beam, Resonator : amplifies the beam, through the Xe-gas contained lamp : Xe-gas contains high pressure lamp to increase specific laser beam lamp This converted light energy creates the ND:YAG crystal and exhaust from the crystal is amplified into a specific wave length. Laser energy produced is delivered to the Tissue by means of an articulated arm and a specially designed multi spot Hand Piece. The Physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam, and is able to activate laser emission using Foot Switch. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit. This system also consist of Optic main Bench assembly, Articulated Arm Hand pieces, LCD control panel, Cooling system, Foot Pedal Switch
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    K Number
    K150997
    Device Name
    RUBY STAR
    Manufacturer
    BISON MEDICAL CO., LTD
    Date Cleared
    2015-12-22

    (251 days)

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

    BISON MEDICAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RUBY STAR Laser Q -switched 694mm Ruby laser system is indicated for cutting, vaporization, and ablation of soft tissue. This includes tattoo removal and treatment of benign pigmented lesions.
    Device Description
    RUBY STAR Q-switched laser system are emitting a beam of coherent light at 694nm with 25-30ns Pulse width, and 0.1 - 200j/cm2 Energy fluence via 7-Articulated arm and consist of - * An articulated arm delivery systems terminated in a hand piece. - * Electronic power supply and interface circuitry - * Optical chamber with laser rod and cavity optics with cooling system. - * LCD color touch screen with foot pedal switch. Laser energy produced is delivered to the Tissue by means of an articulated arm. The Physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam, and is able to activate laser emission using Foot Switch.
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