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510(k) Data Aggregation
K Number
K961299Device Name
PRECISION UV (VASURFILCON A)
Manufacturer
PILKINGTON BARNES-HIND, LTD.
Date Cleared
1996-10-01
(180 days)
Product Code
LPL
Regulation Number
886.5925Why 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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