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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 NameFRESHLOOK RADIANCE SPHERICAL AND TORIC (PHEMFILCON A) SOFT CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Namesoft (hydrophilic) contact lens
Regulation Number886.5925
ApplicantCIBA VISION CORPORATION
PMA NumberP830037
Supplement NumberS047
Date Received10/25/2002
Decision Date11/26/2002
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - color additive
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an additional colorant to be used in the colorant process and a revision to the labeling to move the statement "the lens acts to enhance or alter the apparent color of the eye" from the actions section of the package insert to the indications section. The device, as modified, will be marketed under the freshook trade name with the following indications: vision correction spherical: freshlook spherical (phemfilcon a) soft (hydrophilic) contact lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2. 0 diopters that does not interfere with visual acuity. The lens acts to enhance or alter the apparent color of the eye. Toric freshlook toric (phemfilcon a) soft (hydrophilic) contact lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 6. 0 diopters. The lens acts to enhance or alter the apparent color of the eye. The lenses may be prescribed for daily wear or extended wear in not-aphakic persons from 1 to 7 days between removal for cleaning an disinfection or disposal, as recommended by the eye care professional or for daily wear in aphakic persons. The eye care professional may prescribe the lens in either the single-use disposable wear or for frequent replacement with cleaning, disinfection and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system. Freshlook soft contact lenses with uv-absorbing monomer help protect against transmission of harmful uv radiation to the cornea and into the eye.
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