BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)

    K Number: K182453 · Decision Jan 11, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    18
    Applicant Total
    2
    Review Days
    126

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    Basic Information

    Device Name
    ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)
    K Number
    K182453
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    I-Tech Industries Srl
    Date Received
    September 7, 2018
    Decision Date
    January 11, 2019
    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 I-Tech Industries Srl

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