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510(k) Data Aggregation

    K Number
    K250171
    Device Name
    IPL Hair Removal Device (BE965A, BE965B, BE965C)
    Date Cleared
    2025-03-19

    (57 days)

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

    Shenzhen Yang Wo Electronic Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial hair.
    Device Description
    IPL Hair Removal Device is an over-the-counter, light based device for unwanted hair removal by using Intense Pulsed Light (IPL) technology. The device works below the skin's surface and does not involve any culling, removing hair growth with minimal pain. The device includes three models with the only difference in enclosure color. It is only power adapter and its PL emission activation is by a switch or auto light emission, and it contains a skin sensor to detect appropriate skin contact, if the flash window is not in full contact with the skin, the device cannot emit the treatment light pulses. The device has a sapplire cooling function for a better hair removal experience.
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    K Number
    K241834
    Device Name
    IPL Hair Removal Device (BE932C, BE932D, BE932E)
    Date Cleared
    2024-09-23

    (90 days)

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

    Shenzhen Yang Wo Electronic Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial hair.
    Device Description
    The IPL Hair Removal Device is a hand-held device that utilizes Intense Pulsed Light (IPL) technology. The device works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device includes three models with the only difference in enclosure color. It is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission a skin sensor to detect appropriate skin contact, if the flash window is not in full contact with the skin, the device cannot emit the treatment light pulses. The device has a cooling function for a better hair remove experience.
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    Ask a specific question about this device

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