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

    Lap.Ox™ Laparoscopic Tissue Oximeter

    K Number: K250519 · Decision Jun 26, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    73
    Applicant Total
    1
    Review Days
    125

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    Basic Information

    Device Name
    Lap.Ox™ Laparoscopic Tissue Oximeter
    K Number
    K250519
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ViOptix, Inc.
    Date Received
    February 21, 2025
    Decision Date
    June 26, 2025
    Product Code
    MUD
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MUD Oximeter, Tissue Saturation

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