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

    UV Lamps for Indoor Tanning Devices

    K Number: K151370 · Decision Dec 17, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    80
    Applicant Total
    9
    Review Days
    210

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    Basic Information

    Device Name
    UV Lamps for Indoor Tanning Devices
    K Number
    K151370
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4635
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Light Sources, Inc.
    Date Received
    May 21, 2015
    Decision Date
    December 17, 2015
    Product Code
    LEJ
    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
    LEJ Booth, Sun Tan

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    Other Clearances by Light Sources, Inc.

    K Number Device Name
    K901324 U.V. SUNLAMP 95UF-II
    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