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510(k) Data Aggregation

    K Number
    K961299
    Device Name
    PRECISION UV (VASURFILCON A)
    Manufacturer
    PILKINGTON BARNES-HIND, LTD.
    Date Cleared
    1996-10-01

    (180 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    PILKINGTON BARNES-HIND, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Precision UVM (vasurfilcon A) Hydrophilic contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic and may have 2.00 diopters (D) or less of corneal astigmatism that does not interfere with visual acuity. The contact lenses may be prescribed for daily wear as recommended by the eye care practitioner.
    Device Description
    Precision UV™ (vasurfilcon A) soft (hydrophilic) contact lenses are available as clear and locator unted spherical lenses in the power range from -10.00 to +6.00 diopters, center thicknesses from 0.10 - 0.26 mm (minus lenses) and 0.18 - 0.37 mm (plus lenses) with base curves of 8.4 and 8.7 mm and a diameter of 14.4 mm. The lens material, vasurfilcon A, is a hydrophilic random copolymer of N-vinyl-pyrrolidone (NVP), Methyl methacrylate (MMA), Allyl methacrylate (AMA), Ultraviolet absorbing monomer (UVAM) and AIBN (Azo-Iso-butyronitrile) as an initiator. It consists of 74% water and 26% vasurfilcon A.
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