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

    Empower H65

    K Number: K180423 · Decision Mar 15, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    5
    Review Days
    27

    Basic Information

    Device Name
    Empower H65
    K Number
    K180423
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    quanta system spa
    Date Received
    February 16, 2018
    Decision Date
    March 15, 2018
    Product Code
    GEX
    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
    GEX Powered Laser Surgical Instrument

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    Other Clearances by quanta system spa

    K Number Device Name
    K192600 Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60
    K180922 Empower H100, Cyber Ho 100, Litho 100
    K172025 Litho 60
    K170331 Cyber Ho