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

    Visualase V2 MRI-guided Laser Ablation System (9736422)

    K Number: K250307 · Decision May 29, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    6
    Applicant Total
    9
    Review Days
    115

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    Basic Information

    Device Name
    Visualase V2 MRI-guided Laser Ablation System (9736422)
    K Number
    K250307
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Navigation
    Date Received
    February 3, 2025
    Decision Date
    May 29, 2025
    Product Code
    ONO
    Advisory Committee
    General, Plastic Surgery
    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
    ONO Neurosurgical Laser With Mr Thermography

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