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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 NameSUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN
Classification Namelenses, soft contact, daily wear
Generic Namehydrophylic contact lens
Regulation Number886.5925
ApplicantSUNSOFT CORP.
PMA NumberP850077
Supplement NumberS022
Date Received11/22/1996
Decision Date03/10/1997
Product Code
LPL[ Registered Establishments with LPL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate molded lens manufacturing process. The device, as modified, will be marketed under the trade name sunsoft multiples(tm) and are indicated as follows: 1)multiples toric lenses are indicated for daily wear or extended wear from 1 to 7 days between removals for cleaning and disinfecting as recommended by the eye care professional. The lenses are indicated for the correction of visual acuity in not-aphakic person with nondiseased eyes that are myopic or hyperopic and ahve refractive astigmatism not exceeding 7. 00 diopters (d). 2) multiples spherical lenses are indicated for daily wear or extended wear from 1 to 7 days between removals for cleaning and disinfecting as recommended by the eye care professional. The lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are myopic or hyperopic. The lenses may be worn by persons who exhibit refractive astigmatism of 1. 50 d or less that does not interfere with visual acuity. The lenses range in power from -20. 00 d to +10. 00 d. 3) multiples aphakic lenses are indicated for daily wear or extended wear from 1 to 7 days between removals for cleaning and disinfecting as recommended by the eye care professional. The lenses are indicated for the correction of visual acuity in aphakic persons with nondiseased eyes that are hyperopic. The lenses may be worn by persons who exhibit refractive astigmatism of 1. 50 d or less that does not interfere with visual acuity. The lenses range in power from +10. 50 d to +20. 00 d.
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