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

    IPL Treatment Systems

    K Number: K200746 · Decision May 15, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    93
    Same Product Code
    73
    Applicant Total
    14
    Review Days
    53

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    Basic Information

    Device Name
    IPL Treatment Systems
    K Number
    K200746
    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
    Shanghai Apolo Medical Technology Co., Ltd.
    Date Received
    March 23, 2020
    Decision Date
    May 15, 2020
    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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