BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Electrical Impedance Spectrometer

    PMA: P150046 · Supplement: S005 · Decision Feb 26, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Electrical Impedance Spectrometer
    Trade Name
    Nevisense
    PMA Number
    P150046
    Supplement Number
    S005
    Device Class
    FDA Class 2
    Product Code
    ONV
    Generic Name
    Electrical Impedance Spectrometer
    Regulation Number
    878.1820
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 26, 2026
    Date Received
    December 2, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for replacing the user manual text, “Nevisense may only be used by dermatologists who have successfully completed the Nevisense training”, with the following:• “Only dermatologists, who have completed Nevisense training, may initiate a Nevisense examination and utilize the Nevisense results in conjunction with other clinical parameters toobtain additional information prior to decision to biopsy.”• “Nevisense may only be operated by healthcare professionals who have successfully completed the Nevisense training.”

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ONV Electrical Impedance Spectrometer