BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇪 Belgium

    Demetra Dermatoscope BDEM-01

    K Number: K213957 · Decision Mar 11, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    9
    Applicant Total
    60
    Review Days
    84

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    Basic Information

    Device Name
    Demetra Dermatoscope BDEM-01
    K Number
    K213957
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Barco N.V.
    Date Received
    December 17, 2021
    Decision Date
    March 11, 2022
    Product Code
    PSN
    Advisory Committee
    General, Plastic Surgery
    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
    PSN Light Based Imaging

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