BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    IPL Hair Remover, Model: G993, G996, G998 and G885

    K Number: K211368 · Decision Oct 4, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    93
    Same Product Code
    73
    Applicant Total
    2
    Review Days
    153

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    Basic Information

    Device Name
    IPL Hair Remover, Model: G993, G996, G998 and G885
    K Number
    K211368
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Mywin Technology Co., Ltd.
    Date Received
    May 4, 2021
    Decision Date
    October 4, 2021
    Product Code
    ONF
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

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    Other Clearances by Shenzhen Mywin Technology Co., Ltd.

    K Number Device Name
    K221679 IPL Hair Remover, Model: G993, G996, G998 and G885