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    K Number
    K181568
    Device Name
    IPL Salon Hair Reduction System
    Manufacturer
    Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt
    Date Cleared
    2018-09-11

    (89 days)

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

    Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IPL Salon Hair Reduction System (Model: F60001) is an over the Counter device intended for the removal of unwanted body and/or facial hair in adults. It is also intended for permanent reduction in unwanted hair reduction is defined as the long-term stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen.
    Device Description
    IPL Salon Hair Reduction System, Model: F60001, a small over-the-counter device, is a homeuse device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). Emission activation is by finger switch. Device includes a treatment window head, a facial adaptor and battery charger/AC cord. It is used AC Powered(100-240 V AC; 50/60 Hz).The weight of the device is 650g, and the size is 143 x69.5 x 43mm (H*W*D).The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
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