This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the purevision(tm) (balafilcon a) visibility tinted contact lens. This device is indicated for daily or extended wear from 1 to 7 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care practitioner. 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.
| Device | PURE VISION VISIBILITY TINTED CONTACT LENS FOR EXTENDED WEAR |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 1998-03-06 |
| Decision Date | 1999-02-05 |
| PMA | P980006 |
| Supplement | S |
| Product Code | LPM |
| Docket Number | 99M-0237 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Bausch & Lomb, Inc. 1400 North Goodman St. rochester, NY 14609-3547 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P980006 | Original Filing | |
| S035 | 2022-08-12 | 30-day Notice |
| S034 | 2022-02-22 | 30-day Notice |
| S033 | 2021-12-15 | 30-day Notice |
| S032 | 2021-06-03 | Real-time Process |
| S031 | ||
| S030 | 2020-09-02 | 30-day Notice |
| S029 | 2019-07-15 | Real-time Process |
| S028 | ||
| S027 | 2018-03-12 | 30-day Notice |
| S026 | 2017-12-26 | 30-day Notice |
| S025 | 2015-11-20 | 30-day Notice |
| S024 | 2015-02-20 | 30-day Notice |
| S023 | 2014-09-15 | 30-day Notice |
| S022 | 2014-04-14 | Normal 180 Day Track No User Fee |
| S021 | 2013-06-24 | 30-day Notice |
| S020 | 2011-06-08 | 30-day Notice |
| S019 | 2011-05-19 | 30-day Notice |
| S018 | 2010-12-03 | Normal 180 Day Track No User Fee |
| S017 | 2010-12-01 | 30-day Notice |
| S016 | 2010-12-01 | 30-day Notice |
| S015 | 2010-07-22 | Normal 180 Day Track |
| S014 | 2008-11-12 | Real-time Process |
| S013 | 2008-09-24 | Real-time Process |
| S012 | 2008-04-02 | Real-time Process |
| S011 | 2007-08-20 | 30-day Notice |
| S010 | 2006-08-24 | 30-day Notice |
| S009 | ||
| S008 | 2005-04-25 | Real-time Process |
| S007 | 2005-03-03 | Normal 180 Day Track |
| S006 | 2005-02-03 | Real-time Process |
| S005 | 2004-01-06 | Normal 180 Day Track No User Fee |
| S004 | 2001-05-30 | Panel Track |
| S003 | 2001-01-09 | Normal 180 Day Track |
| S002 | 1999-09-01 | Normal 180 Day Track |
| S001 | 1999-06-29 | Normal 180 Day Track |