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

    LEVIA PHOTOTHERAPY SYSTEM

    K Number: K040062 · Decision Feb 13, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    3
    Review Days
    31

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    Basic Information

    Device Name
    LEVIA PHOTOTHERAPY SYSTEM
    K Number
    K040062
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lerner Medical Devices, Inc.
    Date Received
    January 13, 2004
    Decision Date
    February 13, 2004
    Product Code
    FTC
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    Y

    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 Lerner Medical Devices, Inc.

    K Number Device Name
    K091568 LH-75 PHOTOTHERAPY SYSTEM
    K090097 LH-75T PHOTOTHERAPY SYSTEM