This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for extended wear approval for the frequency 55 uv (methafilcon a) soft (hydrophilic) contact lenses with uv absorbing monomer. These devices, previously cleared for daily wear under k020392, will be marketed under the trade names listed below for the following indications for use:frequency 55 uv and frequency 55 uv aspheric lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfecting as recommended by the eye care practitioner. They are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2. 00 diopters or less that does not interfere with visual acuity. Frequency 55 uv toric lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfecting as recommended by the eye care practitioner. They are indicated for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and not aphakic persons with non-diseased eyes. The lenses may be worn by persons who have astigmatism of 12. 00 diopters or less. Frequency 55 uv multifocal lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfecting as recommended by the eye care practitioner. They are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic. The lenses may be worn by persons who exhibit astigmatism of 2. 00 diopters or less that does not interfere with visual acuity. Frequency 55 lenses with uv absorbing monomer help protect against transmission of harmful uv radiation into the cornea and the eye. Note: only chemical (not heat) and hydrogen peroxide disinfection systems may be used with frequency 55 uv lenses. Frequent/planned replacement when prescribed for...
| Device | FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENS) |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | COOPERVISION, INC. |
| Date Received | 2002-05-15 |
| Decision Date | 2002-06-13 |
| PMA | P850079 |
| Supplement | S040 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | COOPERVISION, INC. 370 Woodcliff Drive suite 200 fairport, NY 14450-0000 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850079 | Original Filing | |
| S089 | 2020-08-03 | 30-day Notice |
| S088 | 2020-06-29 | 30-day Notice |
| S087 | 2020-03-24 | 30-day Notice |
| S086 | 2020-02-13 | 30-day Notice |
| S085 | 2019-10-15 | 30-day Notice |
| S084 | 2019-08-09 | 30-day Notice |
| S083 | 2019-05-13 | 30-day Notice |
| S082 | 2019-04-16 | 30-day Notice |
| S081 | ||
| S080 | 2018-08-09 | Normal 180 Day Track No User Fee |
| S079 | 2018-06-07 | 30-day Notice |
| S078 | 2018-02-14 | 30-day Notice |
| S077 | 2018-01-16 | 135 Review Track For 30-day Notice |
| S076 | 2017-10-26 | 30-day Notice |
| S075 | 2017-09-20 | 30-day Notice |
| S074 | 2017-07-19 | 30-day Notice |
| S073 | 2017-01-30 | 30-day Notice |
| S072 | 2017-01-19 | 30-day Notice |
| S071 | 2016-12-22 | 30-day Notice |
| S070 | 2016-02-12 | 30-day Notice |
| S069 | 2015-10-19 | 30-day Notice |
| S068 | 2015-09-04 | 30-day Notice |
| S067 | 2014-08-08 | 30-day Notice |
| S066 | ||
| S065 | 2013-08-19 | 30-day Notice |
| S064 | 2012-12-19 | 30-day Notice |
| S063 | 2012-12-10 | 135 Review Track For 30-day Notice |
| S062 | 2012-11-09 | 30-day Notice |
| S061 | 2012-10-24 | 30-day Notice |
| S060 | 2012-10-23 | 30-day Notice |
| S059 | 2012-10-09 | 30-day Notice |
| S058 | 2012-10-09 | 30-day Notice |
| S057 | 2012-09-20 | 30-day Notice |
| S056 | 2012-08-24 | 30-day Notice |
| S055 | 2012-08-20 | 30-day Notice |
| S054 | 2012-08-20 | 30-day Notice |
| S053 | 2012-06-12 | 30-day Notice |
| S052 | 2012-04-10 | 30-day Notice |
| S051 | 2011-11-01 | 30-day Notice |
| S050 | 2011-08-16 | Normal 180 Day Track No User Fee |
| S049 | 2011-01-28 | 30-day Notice |
| S048 | 2010-02-16 | 135 Review Track For 30-day Notice |
| S047 | 2009-12-28 | Normal 180 Day Track No User Fee |
| S046 | 2009-10-13 | 135 Review Track For 30-day Notice |
| S045 | 2009-03-18 | 30-day Notice |
| S044 | ||
| S043 | 2008-05-27 | 30-day Notice |
| S042 | 2005-05-03 | Normal 180 Day Track No User Fee |
| S041 | 2002-08-20 | Normal 180 Day Track |
| S040 | 2002-05-15 | Normal 180 Day Track |
| S039 | 2001-12-06 | Normal 180 Day Track |
| S038 | 2001-06-01 | Normal 180 Day Track |
| S037 | 2000-08-16 | Normal 180 Day Track |
| S036 | 2000-03-06 | 30-day Notice |
| S035 | ||
| S034 | 2000-02-02 | Normal 180 Day Track |
| S033 | ||
| S032 | 1999-09-28 | Normal 180 Day Track |
| S031 | 1999-04-14 | Normal 180 Day Track |
| S030 | 1999-03-11 | Normal 180 Day Track |
| S029 | 1998-01-20 | Normal 180 Day Track |
| S028 | 1996-07-12 | Normal 180 Day Track |
| S027 | 1996-06-19 | Normal 180 Day Track |
| S026 | 1995-03-31 | 30-Day Supplement |
| S025 | 1994-05-04 | Special (immediate Track) |
| S024 | 1993-02-25 | Normal 180 Day Track |
| S023 | ||
| S022 | ||
| S021 | 1991-12-11 | Normal 180 Day Track |
| S020 | 1991-11-04 | Normal 180 Day Track |
| S019 | 1991-07-15 | Normal 180 Day Track |
| S018 | 1990-12-10 | Normal 180 Day Track |
| S017 | 1990-12-07 | Normal 180 Day Track |
| S016 | 1990-01-31 | Normal 180 Day Track |
| S015 | 1990-01-17 | Normal 180 Day Track |
| S014 | 1989-06-12 | Normal 180 Day Track |
| S013 | 1989-02-06 | Normal 180 Day Track |
| S012 | 1988-12-09 | Normal 180 Day Track |
| S011 | 1988-09-19 | Normal 180 Day Track |
| S010 | 1988-04-08 | Normal 180 Day Track |
| S009 | 1987-11-12 | Normal 180 Day Track |
| S008 | 1987-11-04 | Special (immediate Track) |
| S007 | 1987-03-03 | 30-Day Supplement |
| S006 | ||
| S005 | 1986-09-12 | Normal 180 Day Track |
| S004 | 1986-07-28 | Normal 180 Day Track |
| S003 | 1986-07-18 | Normal 180 Day Track |
| S002 | 1986-07-18 | Normal 180 Day Track |
| S001 | 1985-10-02 |