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

    U.V. SUNLAMP 95UF-II

    K Number: K901324 · Decision Apr 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    9
    Review Days
    36

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    Basic Information

    Device Name
    U.V. SUNLAMP 95UF-II
    K Number
    K901324
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Light Sources, Inc.
    Date Received
    March 21, 1990
    Decision Date
    April 26, 1990
    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 Light Sources, Inc.

    K Number Device Name
    K151370 UV Lamps for Indoor Tanning Devices
    K900649 FLUORESCENT T12 UVA LAMP
    K900693 U.V. SUNLAMP (U.V. LIGHT, DERMATOLOGIC)
    K883952 U. V. SUNLAMP 95UF-11
    K874889 U.V. SUNLAMP 95 UF-11
    K870167 U.V. SUNLAMP 95UF-11
    K854004 FLUORESCENT T12 UVA TANNING LAMP
    K853545 FLOURESCENT T12 UVA TANNING LAMP