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

    ICOONE Laser Med (also referred to as ICOONE Medical laser)

    K Number: K211272 · Decision Jun 22, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    18
    Applicant Total
    2
    Review Days
    56

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    Basic Information

    Device Name
    ICOONE Laser Med (also referred to as ICOONE Medical laser)
    K Number
    K211272
    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
    I-Tech Industries Srl
    Date Received
    April 27, 2021
    Decision Date
    June 22, 2021
    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

    K Number Device Name
    K182453 ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)