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510(k) Data Aggregation

    K Number
    K230107
    Device Name
    Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588
    Manufacturer
    Kam Yuen Plastic Products Ltd.
    Date Cleared
    2023-04-05

    (82 days)

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

    Kam Yuen Plastic Products Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aimanfun Lumea Comfort is an over-the-counter device intended for removal of unwanted body and/or facial hair.
    Device Description
    Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 is an over-the-counter use device for the reduction of hair growth. Ideal body areas include the underarms, bikini line, arms and legs. The device used the Intense Pulsed Light (IPL) technology with lower energy level, including 5 Levels of output energy. Intense Pulsed light technology is able to achieve hair removal results at a fraction of the energy level used in other light-based hair removal equipment. The hand-held device package includes main unit, adaptor and user manual and it uses a Xenon Lamp to emit specified wavelength pulsed light to heat the root where the hair grows, and a skin proximity 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.
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    K Number
    K213025
    Device Name
    Laser hair growth helmet
    Manufacturer
    Kam Yuen Plastic Products Ltd.
    Date Cleared
    2022-05-12

    (233 days)

    Product Code
    OAP
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kam Yuen Plastic Products Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Laser hair growth helmet (Model: A-800) is intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I-II, and in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa-V; and both genders having Fitzpatrick Classification of Skin Phototypes I-IV.
    Device Description
    The Laser hair growth helmet (Model: A-800) is hands-free, portable, non-invasive, low-level laser device, which consists of red visible light diode lasers, to produce red light operating at 650nm wavelength (maximum output power of each is 5mW). The laser sources are arranged in a dot matrix arrangement in the inner of the helmet, which could take into account of every hair follicle and promote rapid hair growth. The device will automatically suspend the work if it is removed from scalp, and the power blue light indicator flashes.
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    K Number
    K212907
    Device Name
    Aimanfun Lumea Comfort, A-2789/A-3588
    Manufacturer
    Kam Yuen Plastic Products Ltd.
    Date Cleared
    2021-12-02

    (80 days)

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

    Kam Yuen Plastic Products Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aimanfun Lumea Comfort (Model: A-2789, A-3588) 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 Aimanfun Lumea Comfort 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
    Aimanfun Lumea Comfort is a light-based device for long-term hair removal, designed for home environment used. 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 is able to achieve long-term hair removal results at a fraction of the energy level used in other light-based hair removal equipment. The device uses a Xenon Lamp to emit specified wavelength pulsed light to heat the root where the hair grows, and a skin proximity 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 device is a home-use and hand-held device consists of main unit and adaptor, for the permanent reduction of hair growth based on Intense Pulsed Light (IPL).
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