BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Visualase Thermal Therapy System

    K Number: K181859 · Decision Mar 6, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    3
    Review Days
    237

    Basic Information

    Device Name
    Visualase Thermal Therapy System
    K Number
    K181859
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Navigation Inc.
    Date Received
    July 12, 2018
    Decision Date
    March 6, 2019
    Product Code
    LLZ
    Advisory Committee
    Radiology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LLZ System, Image Processing, Radiological

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