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

    UVA PHOTOTHERAPY SYSTEM

    K Number: K761094 · Decision Dec 2, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    5
    Review Days
    9

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    Basic Information

    Device Name
    UVA PHOTOTHERAPY SYSTEM
    K Number
    K761094
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Dermatron Corp.
    Date Received
    November 23, 1976
    Decision Date
    December 2, 1976
    Product Code
    KGL
    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
    KGL Cabinet, Phototherapy (Puva)

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    Other Clearances by Dermatron Corp.

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    K760482 SUNLAMP (F40-UVB & F20-UVB)
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