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510(k) Data Aggregation

    K Number
    K221001
    Device Name
    IPL Home Use Hair Removal Device
    Manufacturer
    Shenzhen Beauty Every Moment intelligent electric Co.,Ltd.
    Date Cleared
    2022-05-12

    (38 days)

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

    Shenzhen Beauty Every Moment intelligent electric Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
    Device Description
    The IPL Home Use Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting. The IPL Home Use Hair Removal Device includes D-1198, D-1186, D-1189, D-1197 five models. Their intended use, performance, structure design and operation are basically identical, with the differences mainly contains PCB layout, product appearance and internal construction, but these differences do not affect or change the intended use of the device.
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    K Number
    K211922
    Device Name
    IPL Home Use Hair Removal Device
    Manufacturer
    Shenzhen Beauty Every Moment intelligent electric Co.,Ltd.
    Date Cleared
    2021-09-20

    (91 days)

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

    Shenzhen Beauty Every Moment intelligent electric Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
    Device Description
    The IPL Home Use Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting. The IPL Home Use Hair Removal Device includes D-1129, D-1130, D-1119, D-1119, D-1103, D-1176, D-1151, D-T1002 eight models. Their intended use, performance, structure design and operation are basically identical, with the differences contains product appearance, display contents, lamp cartridge's quantity and appearance as well as the placement location of lamp tube; in additional, due to the size of the treatment window in different lamp cartridge, the treatment area (spot size) and output density is a little different; but these differences do not affect or change the intended use of the device.
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