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510(k) Data Aggregation

    K Number
    K211735
    Device Name
    CO2 Laser Machine, Model: BW-203B
    Manufacturer
    Zhengzhou Bestview St Co., Ltd.
    Date Cleared
    2021-10-22

    (137 days)

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

    Zhengzhou Bestview St Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CO2 Laser Machine is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
    Device Description
    The CO2 Laser Machine is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. The CO2 laser machine has two modes, continuous mode and multi-pulse mode. It utilizes CO2 laser to vaporize and heat tissue. During the treatment, the water in skin tissues absorbs laser energy and then vaporizes. Laser parameters and other system features are controlled from the control panel on the console, which provides an interface to the system's micro-controller through a LCD touch-screen.
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    K Number
    K211335
    Device Name
    Diode Laser Machine, Model Number: BM-100
    Manufacturer
    Zhengzhou Bestview St Co., Ltd.
    Date Cleared
    2021-07-28

    (86 days)

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

    Zhengzhou Bestview St Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diode Laser Machine (Model: BM-100) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
    Device Description
    The proposed device incorporates a diode laser that emits invisible infrared laser radiation centered on a wavelength of 808 nm. Main components of the device include the laser console, liquid crystal display (LCD) touchscreen control panel, and laser handpiece. The device emits pulses of the 808 nm infrared laser emissions at pulse widths, repetition frequency, and energy levels, conductive to hair removal. The device incorporates water cooling, air cooling fan, and switches/buttons to control the laser output. The device is powered via an alternating current power source.
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