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

    Ultravision Visual Field Clearing System

    K Number: K170178 · Decision May 26, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    6
    Applicant Total
    6
    Review Days
    127

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Ultravision Visual Field Clearing System
    K Number
    K170178
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5050
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alesi Surgical, Ltd.
    Date Received
    January 19, 2017
    Decision Date
    May 26, 2017
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PQM), ordered by most recent decision date.

    Ultravision2™ IonPencil

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Ultravision2™ System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Ultravision2™ System Integrated Monopolar L-Hook (H/S)™

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Ultravision Visual Field Clearing System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Ultravision™ Visual Field Clearing System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Ultravision Visual Clearing System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Alesi Surgical, Ltd.

    K Number Device Name
    K231238 Ultravision2™ System
    K231298 Ultravision2™ System Integrated Monopolar L-Hook (H/S)™
    K200035 Ultravision Visual Field Clearing System
    K182053 Ultravision™ Visual Field Clearing System
    DEN150022 Ultravision Visual Clearing System