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510(k) Data Aggregation

    K Number
    K243030
    Device Name
    Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)
    Manufacturer
    Ulike Co., Ltd.
    Date Cleared
    2024-10-25

    (28 days)

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

    Ulike Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diamond Air+ is an over-the-counter device intended for removal of unwanted body and/or facial hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the longterm, 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
    Diamond Air+, Model: UI04A, UI04B, UI04C, UI04M, UI04G, UI04W is a light-based device for long-term hair removal. It is intended for the removal of unwanted hair and permanent reduction in hair regrowth. Ideal body areas include the underarms, bikini line, arms and legs. The device used the IPL technology with lower energy level, including 5 Levels of output energy. Intense Pulsed light technology can achieve long-term hair removal results at a fraction of the energy level used in other light -based hair removal equipment. The size of the device is about 60*38*169.86mm (W x D x H). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. The device contains a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the Diamond Air+ is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.
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    K Number
    K221553
    Device Name
    Diamond Air+ (UI04A, UI04B, UI04C)
    Manufacturer
    Ulike Co., Ltd
    Date Cleared
    2022-09-15

    (107 days)

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

    Ulike Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diamond Air+ is an over-the-counter device intended for removal of unwanted body and/or facial 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
    Diamond Air+ (Model: UI04A, UI04B, UI04C) is a light-based device for long-term hair removal intended to be sold over-the-counter directly to the end user. The subject device is identical to that cleared via K213558. It is intended for the removal of unwanted hair and permanent reduction in hair regrowth. Ideal body areas include the underarms, bikini line, arms and legs. The device utilizes the IPL technology with 5 Levels of output energy. The size of the device is 60*38*169.86mm (W x D x H). It contains a Xenon Lamp and a skin contact sensor to detect appropriate skin application. If the IPL Hair Removal Device is not properly applied to the treatment area (in full contact with not start treatment.
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    K Number
    K213558
    Device Name
    IPL Hair Removal Device
    Manufacturer
    Ulike Co., Ltd
    Date Cleared
    2022-03-08

    (120 days)

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

    Ulike Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IPL Hair Removal Device (Model: U104A, U104C) is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. The IPL Hair Removal Device is also intended for permanent reduction in unwanted hair. Permanent hair reduction is 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 regimen.
    Device Description
    IPL Hair Removal Device, Model: UI04A, UI04B, UI04C, is a light-based device for long-term hair removal. It is intended for the removal of unwanted hair and permanent reduction in hair regrowth. Ideal body areas include the underarms, bikini line, arms and legs. The device used the IPL technology with lower energy level, including 5 Levels of output energy. Intense Pulsed light technology can achieve long-term hair removal results at a fraction of the energy level used in other light -based hair removal equipment. The size of the device is about 60*38*169.86mm (W x D x H). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. The device contains a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the IPL Hair Removal Device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.
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