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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 NameBIOFINITY ENERGYS ASPHERE, BIOFINITY XR TORIC, BIOFINITY XR MULTIFOCAL
Classification Namelenses, soft contact, extended wear
Generic Namecomfilcon a soft (hydrophilic) contact lenses for extended wear
Regulation Number886.5925
ApplicantCOOPERVISION, INC.
PMA NumberP080011
Supplement NumberS035
Date Received12/16/2014
Decision Date03/11/2015
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in trade name for the biofinity energys aspheric lens and expanded powers for the biofinity xr toric and biofinity xr multifocal lenses. The devices, as modified, will be marketed under the trade names biofinity energys asphere, biofinity xr toric, and biofinity xr multifocal (comfilcon a) soft (hydrophilic) contact lenses for extended wear and are indicated for: biofinity energys asphere (comfilcon a) soft contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20. 00 to +20. 00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2. 00 diopters or less that does not interfere with visual acuity. Biofinity xr toric (comfilcon a) soft contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20. 00 to +20. 00 d and astigmatism corrections from -0. 25 to -5. 75 d. Biofinity xr multifocal (comfilcon a) lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) with emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20. 00 to +20. 00 d and with add powers from +0. 05 to +4. 00 d. The lenses may be worn by persons who exhibit astigmatism of 2. 00 d or less that does not interfere with visual acuity.
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