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510(k) Data Aggregation

    K Number
    K173813
    Device Name
    IPL Hair Removal Device Joy Version
    Manufacturer
    Shen Zhen CosBeauty Co., Ltd
    Date Cleared
    2018-09-07

    (266 days)

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

    Shen Zhen CosBeauty Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IPL Hair Removal Device Joy Version 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. The device is used for adults with Fitzpatrick skin types I - IV.
    Device Description
    IPL Hair Removal Device Model: CB-027, 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 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 402g, and the size is 126 x 78 x 200mm (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.
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