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

    Enhanced AURORA™ Medical Diode System, and related accessories

    K Number: K230076 · Decision Mar 8, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    2
    Review Days
    57

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    Basic Information

    Device Name
    Enhanced AURORA™ Medical Diode System, and related accessories
    K Number
    K230076
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Psoria-Shield, Inc.
    Date Received
    January 10, 2023
    Decision Date
    March 8, 2023
    Product Code
    FTC
    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
    FTC Light, Ultraviolet, Dermatological

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    Other Clearances by Psoria-Shield, Inc.

    K Number Device Name
    K103540 PSORIA-LIGHT