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

    SUN BEDS

    K Number: K851255 · Decision Apr 18, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    7
    Review Days
    21

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    Basic Information

    Device Name
    SUN BEDS
    K Number
    K851255
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Tannhut
    Date Received
    March 28, 1985
    Decision Date
    April 18, 1985
    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 Tannhut

    K Number Device Name
    K851859 FACIAL/UPPER BODY UNIT
    K851858 FOLD AWAY HUT
    K840137 SILGMANN SOLARIUM S-TYPE 1218 COMBO
    K837283 UNKNOWN
    K812579 SUNTANNING HOME UNIT
    K802756 SEMI-OVAL MODULAR SUNTANNING BOOTH