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

    Slimming Treatment Device

    K Number: K161892 · Decision Mar 2, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    18
    Applicant Total
    5
    Review Days
    234

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    Basic Information

    Device Name
    Slimming Treatment Device
    K Number
    K161892
    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
    Beijing Honkon Technologies Co., Ltd.
    Date Received
    July 11, 2016
    Decision Date
    March 2, 2017
    Product Code
    NUV
    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
    NUV Massager, Vacuum, Light Induced Heating

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    Other Clearances by Beijing Honkon Technologies Co., Ltd.

    K Number Device Name
    K131838 DIODE LASER FOR HIAR REMOVAL
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