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

    308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)

    K Number: K244022 · Decision Mar 13, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    6
    Review Days
    76

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    Basic Information

    Device Name
    308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)
    K Number
    K244022
    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
    Boston Aesthetics, Inc.
    Date Received
    December 27, 2024
    Decision Date
    March 13, 2025
    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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