BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇬🇧 United Kingdom

    Ultravision Visual Clearing System

    K Number: DEN150022 · Decision Dec 20, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    6
    Applicant Total
    6
    Review Days
    574

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    Basic Information

    Device Name
    Ultravision Visual Clearing System
    K Number
    DEN150022
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    878.5050
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Alesi Surgical, Ltd.
    Date Received
    May 26, 2015
    Decision Date
    December 20, 2016
    Product Code
    PQM
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PQM Surgical Smoke Precipitator

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    Other Clearances by Alesi Surgical, Ltd.

    K Number Device Name
    K231238 Ultravision2™ System
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