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

    Prismira

    K Number: K243729 · Decision Jun 13, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    192

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    Basic Information

    Device Name
    Prismira
    K Number
    K243729
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5803
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lumos Labs, Inc.
    Date Received
    December 3, 2024
    Decision Date
    June 13, 2025
    Product Code
    QFT
    Advisory Committee
    Obstetrics/Gynecology
    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
    QFT Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder

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