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510(k) Data Aggregation

    K Number
    K241881
    Device Name
    IPL Hair Removal Device (JM-843, JM-865, JM-638)
    Date Cleared
    2024-08-29

    (62 days)

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

    SHENZHEN JUNMEI TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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 reduction by using Intense Pulsed Light (PL), and it has been designed 3 models with the same IPL technology for hair removal, which is model JM-843, M-865, JM-638. 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 is by finger switch. IPL Hair Removal Device is a Pulsed Light system which emits intense pulsed light (IPL) at a wavelength ranging from 530-1200m and 500-1200m. The device works on the principles of selective photothermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores thermal relaxation time but sparing normal skin by limiting the thermal relaxation time for skin.
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