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

    VERSA LITE

    K Number: K073503 · Decision Jan 23, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    3
    Review Days
    41

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    Basic Information

    Device Name
    VERSA LITE
    K Number
    K073503
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diomedics, Inc.
    Date Received
    December 13, 2007
    Decision Date
    January 23, 2008
    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 Diomedics, Inc.

    K Number Device Name
    K982546 PHASER-2000
    K926224 DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS