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

    PRECISION UV (VASURFILCON A)

    K Number: K961299 · Decision Oct 1, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    472
    Applicant Total
    4
    Review Days
    180

    Basic Information

    Device Name
    PRECISION UV (VASURFILCON A)
    K Number
    K961299
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    PILKINGTON BARNES-HIND, LTD.
    Date Received
    April 4, 1996
    Decision Date
    October 1, 1996
    Product Code
    LPL
    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
    LPL Lenses, Soft Contact, Daily Wear

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    Other Clearances by PILKINGTON BARNES-HIND, LTD.

    K Number Device Name
    K952261 HYDROCURVE 3 TORIC, II, II 55% TORIC, II APHAKIC 55%, SOFT MATE II, CUSTOM EYES 55%
    K946012 PRECISION UV(TM) (VASURFICON A)
    K944722 PRECISION UV(TM) (VASURFILCON A)