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

    LAMP, FLOURESCENT BLACK, HIGH OUTPUT

    K Number: K760471 · Decision Sep 15, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    5
    Review Days
    27

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    Basic Information

    Device Name
    LAMP, FLOURESCENT BLACK, HIGH OUTPUT
    K Number
    K760471
    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
    August 19, 1976
    Decision Date
    September 15, 1976
    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 Dermatron Corp.

    K Number Device Name
    K770862 BLACK LAMPS,F72T12/BL/HO
    K761094 UVA PHOTOTHERAPY SYSTEM
    K760482 SUNLAMP (F40-UVB & F20-UVB)
    K760519 SUNLAMP, FLOURESCENT DERMATRON F40-313 AND F20-313