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510(k) Data Aggregation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Hair Removal Device is indicated for the removal of unwanted 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

    Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed eighteen models with the same IPL technology for hair removal, which is model CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017, DT017 Pro, DT025 Pro, DT025. The device 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 Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.0cm2 (Model CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X) and 4.2cm2 (Model DT015 Pro, DT015, DT017, DT017 Pro, DT025, DT025 Pro) that is suitable for multiple hair removal areas, such as upper lip, chin, armpits, legs, arms, bikini area, chest, back, abdomen.

    The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the Hair Removal Device has the Ice-cooling function (Model: CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12) and Sapphire Ice-cooling function (Model: CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017, DT017 Pro, DT025 Pro, DT025), which will be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.

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