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

    Ultravision™ Visual Field Clearing System

    K Number: K182053 · Decision Sep 7, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    6
    Applicant Total
    6
    Review Days
    38

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    Basic Information

    Device Name
    Ultravision™ Visual Field Clearing System
    K Number
    K182053
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.5050
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alesi Surgical, Ltd.
    Date Received
    July 31, 2018
    Decision Date
    September 7, 2018
    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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    K200035 Ultravision Visual Field Clearing System
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