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510(k) Data Aggregation

    K Number
    K240016
    Device Name
    IPL Hair Removal Device (YT01,YT02,YT03,YT04)
    Manufacturer
    Shenzhen Jianrong Biomedical Electronics Co., Ltd
    Date Cleared
    2024-07-10

    (190 days)

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

    Shenzhen Jianrong Biomedical Electronics Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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
    IPL Hair Removal Device (Models:YT01, YT02, YT04) is an over-the-counter, home-use and single-person-use device for hair reduction by using Intense Pulsed Light (IPL)to emit a specific wavelength of the light ranging from 550-1200nm and delivers to the skin. The device is designed to help break the cycle of hair re-growth. 550 filter is applied in models YT01&YT02, 600 filter is applied in model YT03 and 640 filter is applied in model YT04.
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