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510(k) Data Aggregation

    K Number
    K220794
    Device Name
    10PL
    Manufacturer
    Date Cleared
    2022-11-10

    (237 days)

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

    Tentech Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Photo therapy unit (model: 10PL) is intended for use in surgical and aesthetic applications in dermatology by using filtered Intense Pulsed Light to treat the following conditions with different wavelengths to skin types I-IV. | Wavelengths | Conditions | |---------------|---------------------------| | 415nm - 950nm | Melasma | | 570nm - 950nm | Melasma, Rosacea | | 590nm - 950nm | Rosacea, Port wine stains |
    Device Description
    10PL is IPL device of Tentech Co., Ltd. that has technical advantages which adopted the rotary filter which can change wavelength band by rotating a revolver without replacing handpieces or filters unlike the existing IPL (Intense Pulsed Light). When the key switch is turned on for the first time [ON], the power supply to remove noise by receiving general power (AC120V) from the block diagram is applied to the SMPS to obtain the power supply and DC12V, the power used for the motor pump and cooling fan and the main control board. POWER SUPPLY is a device that charges DC high voltage using SMPS by receiving stable power, and generates maximum DC600V±10% to charge the CAPACITOR. When the charged DC voltage is applied to the xenon lamp of the handpiece, a desired wavelength is selected among the emitted rays, and the push button switch is pressed the rays are irradiated. In order to use the light irradiator safely, a motor pump and a cooling fan are used to circulate the coolant to cool the xenon lamp and operate the thermoelectric module in the handpiece to keep the folter set to the desired temperature. Set the output intensity and operation mode on the touch screen operation panel of the LCD monitor of the main control board, and select the READY button to turn on the xenon lamp, and press the push button switch to irradiate the light.
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