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510(k) Data Aggregation

    K Number
    K252618
    Date Cleared
    2025-11-14

    (87 days)

    Product Code
    Regulation Number
    878.4810
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial hair.

    Device Description

    IPL Hair Removal Device, is an over-the-counter, home-use device for unwanted hair removing by using Intense Pulsed Light (IPL), and it has been designed three models with the same IPL technology for hair removal, which is model I6 S1, I6 D1 and I6 M1. The device works below the skin's surface and does not involve any cutting or pulling, removing hair growth with minimal pain.

    Model I6 S1 adopts single pulse technology, I6 D1 adopts dual pulse technology, and I6 M1 can switch between single pulse and dual pulse.

    The device is only powered by the external power adapter and its IPL emission activation is by finger switch or auto flash mode.

    The IPL Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.3cm² that is suitable for multiple hair removal areas, such as limbs, armpits, upper lip, back, chest, bikini area.

    The device contains a skin sensor to detect appropriate skin contact, if the flash window is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Hair Removal Device has the sapphire ice cooling function, 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.

    AI/ML Overview

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