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

    Various Brands of Ultraviolet Lamps

    K Number: K150778 · Decision May 29, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    80
    Applicant Total
    4
    Review Days
    65

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    Basic Information

    Device Name
    Various Brands of Ultraviolet Lamps
    K Number
    K150778
    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
    Cosmedico Light, Inc.
    Date Received
    March 25, 2015
    Decision Date
    May 29, 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 Cosmedico Light, Inc.

    K Number Device Name
    K152273 Cosmedico Ultraviolet Lamps of Various Models
    K152095 Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as metal halide sunlamps)
    K935854 ULTRAVIOLET LAMPS FOR TANNING