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

    ML24000 UVA-1 PHOTOTHERAPY UNIT

    K Number: K103708 · Decision Feb 22, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    269
    Applicant Total
    1
    Review Days
    64

    Basic Information

    Device Name
    ML24000 UVA-1 PHOTOTHERAPY UNIT
    K Number
    K103708
    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
    THE DAAVLIN DISTRIBUTING COMPANY
    Date Received
    December 20, 2010
    Decision Date
    February 22, 2011
    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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