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

    ULTRA-VIOLET EMITTING SUNLAMP PRODUCT

    K Number: K842384 · Decision Aug 8, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    3
    Review Days
    51

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    Basic Information

    Device Name
    ULTRA-VIOLET EMITTING SUNLAMP PRODUCT
    K Number
    K842384
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Sola-Tan Intl.
    Date Received
    June 18, 1984
    Decision Date
    August 8, 1984
    Product Code
    FTC
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    RA
    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 Sola-Tan Intl.

    K Number Device Name
    K850042 SOLAR TAN - SOLARIA IV
    K842575 ULTRA-VIOLET A SOURCE LIGHT EMITTING