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

    RESIDENTIAL TANNING UNIT

    K Number: K861076 · Decision Apr 14, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    2
    Review Days
    24

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    Basic Information

    Device Name
    RESIDENTIAL TANNING UNIT
    K Number
    K861076
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Sunmaker, Inc.
    Date Received
    March 21, 1986
    Decision Date
    April 14, 1986
    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 Sunmaker, Inc.

    K Number Device Name
    K803090 SUNMAKER (SUN TANNING BED)