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510(k) Data Aggregation

    K Number
    K220248
    Device Name
    Home use hair removal device
    Manufacturer
    Shenzhen Mareal Tech Co., Ltd
    Date Cleared
    2022-07-01

    (151 days)

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

    Shenzhen Mareal Tech Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Home use hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, in patients with Fitzpatrick Skin Phototypes I-V.
    Device Description
    The 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 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 activation 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 and fully applied to the skin of the treatment area, the device will not emit light pulses.
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    K Number
    K172883
    Device Name
    Home Use Hair Removal Device/T1, T2, T3
    Manufacturer
    Shenzhen Mareal Tech Co., Ltd
    Date Cleared
    2018-02-12

    (144 days)

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

    Shenzhen Mareal Tech Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted hair from small areas such as, but not limited to, underarm and facial hair below the chin line and large areas such as legs, in patients with Fitzpatrick Skin Phototypes I-V.
    Device Description
    The 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 IPL technology. And it consists of IPL main device and AC adapter, and a detachable lamp cap located in the IPL main device which is the source of optical radiation, namely a Xenon flashlamp. The Home Use Hair Removal Device includes three models, T1, T2 and T3. All three models are exactly the same with the exception of the LCD display contents (mainly as the symbol of treatment level). T1 and T3 both adopt shape identification to display the treatment levels, which T1 adopts fan-shaped display and T3 adopts rectangle-shaped display. And T2 direct adopts digital symbol to display treatment levels.
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