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510(k) Data Aggregation

    K Number
    K171648
    Device Name
    BM.IRIS
    Manufacturer
    Bluecore Co.,Ltd.
    Date Cleared
    2017-09-08

    (95 days)

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

    Bluecore Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IRIS Q-switched Nd : YAG Laser System is indicated for the incision, ablation, vaporization of soft tissues for general dermatologic and general surgical procedures for coagulation and hemostasis. 532nm Wavelength: Tattoo removal light ink (red, tan, purple, orange, sky blue,) Removal of Benign Epidermal Pigmented Lesions, Minor Benign Vascular Lesions, Talangiectasias Treatment of Lentigines, Cafe-Au-Lait, Sebrorrheic Keratoses, Becker's Nevi. Freckles Treatment of Post Inflammatory Hyperpigmentation (PIH) 1064nm Wavelength: Tattoo removal: dark ink (black, blue, green ) 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 IRIS Q-Switched Nd: YAG laser system produces a two pulsed beam, 1064 nm Infrared and 532nm long pulse laser, and using different Handpiece able to control various treatment fluence. 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 lamp : Xe-gas contains high pressure lamp to increase specific laser beam This converted light energy creates the Nd: Y AG 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 This device has optional 180mm Dye Hand Pieces to able to switch to 585nm or 650nm from 532nm.
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