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

    TANIT COMMERCIAL SUNTAN BOOTH

    K Number: K801017 · Decision Jun 17, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    2
    Review Days
    48

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    Basic Information

    Device Name
    TANIT COMMERCIAL SUNTAN BOOTH
    K Number
    K801017
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Tanit, Inc.
    Date Received
    April 30, 1980
    Decision Date
    June 17, 1980
    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 Tanit, Inc.

    K Number Device Name
    K800950 TANIT HOME SUNTANNING UNIT