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

    VARILUX VISIONPRINT SYSTEM (VPS)

    K Number: K033949 · Decision Jul 2, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    196

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    Basic Information

    Device Name
    VARILUX VISIONPRINT SYSTEM (VPS)
    K Number
    K033949
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1510
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Essilor Intl.
    Date Received
    December 19, 2003
    Decision Date
    July 2, 2004
    Product Code
    HLL
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HLL Monitor, Eye Movement

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