BEUDAMED
    FDA 510(k) Substantially Equivalent 🇮🇪 Ireland

    VERAFEYE Imaging and Guidance System (VF-VIS-002)

    K Number: K260885 · Decision Jun 15, 2026
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    VERAFEYE Imaging and Guidance System (VF-VIS-002)
    K Number
    K260885
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Luma Vision Limited
    Date Received
    March 17, 2026
    Decision Date
    June 15, 2026
    Advisory Committee
    Unknown
    Review Advisory Committee
    CV
    Third Party
    N

    Other Clearances by Luma Vision Limited

    K Number Device Name
    K242893 VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System