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510(k) Data Aggregation

    K Number
    K161565
    Device Name
    DUO
    Manufacturer
    STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD
    Date Cleared
    2016-09-01

    (87 days)

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

    STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DUO (Model: IPL-HH380-IT) is an over the Counter device intended for the removal of unwanted body and/or facial hair in adults. The DUO 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
    DUO, Model: IPL-HH380-IT,a small over-the-counter,is a home-use device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.A personal Light-Based Hair Removal System.Emission activation is by finger switch.Device includes a treatment window head,a facial adaptor and battery charger/AC cord.lt is used AC Powered(100-240 V AC; 50/60 Hz).The weight of the device is 280g, and the size is 130 x 70 x 30 mm (H x W x D).The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.The device contains a Quartz Xenon Lamp,a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the DUO is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the DUO will not trigger a pulse. The spot size (treatment area) in the DUO device is 3 cm². When the lamp had been subjected to operation of 300000 cycles, then the indicator light on the device is flashing at the frequency of 2Hz , it means that the device life has reached the end, the device stops working.
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