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

    UVB LIGHT BOX - UVB LIGHT BOOTH

    K Number: K792500 · Decision Feb 19, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    4
    Review Days
    77

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    Basic Information

    Device Name
    UVB LIGHT BOX - UVB LIGHT BOOTH
    K Number
    K792500
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Sun Shanty, Inc.
    Date Received
    December 4, 1979
    Decision Date
    February 19, 1980
    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 Sun Shanty, Inc.

    K Number Device Name
    K832482 COMBO UVB/UVA TANNING BOOTHS 8-40-12-36
    K837032 UVB LIGHT BOX TANNING BOOTH
    K813307 UVA HEX UNIT