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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePUREVISION(TM)(BALAFILCON A) VISIBILITY TINTED CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Namebalafilcon a visibility tinted contact lens
Regulation Number886.5925
ApplicantBAUSCH & LOMB, INC.
PMA NumberP980006
Supplement NumberS004
Date Received05/30/2001
Decision Date11/20/2001
Product Code
LPM[ Registered Establishments with LPM ]
Docket Number 01M-0531
Notice Date 11/29/2001
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the pure vision (balafilcon a) visibility tinted contact lens. The device is indicated for daily wear or extended wear from 1 to 30 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional. The lens is indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2. 00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed for frequent/planned replacement wear or disposable wear in spherical powers ranging from +8. 00d to -20. 00d when prescribed for up to 30 days of extended wear and from +20. 00d to -20. 00d for daily wear or extended wear up to 7 days.
Approval Order Approval Order
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