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.
Use ultra-violet bulbs manufactured at a new facility in the soflens 38 (polymacon) contact lens manufacturing process.
| Device | SofLens 38 (polymacon) Visibility Tinted Contact Lens |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 2018-05-15 |
| Decision Date | 2018-06-11 |
| PMA | N16895 |
| Supplement | S101 |
| Product Code | LPM |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Bausch & Lomb, Inc. 1400 North Goodman St. rochester, NY 14609-3547 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N16895 | Original Filing | |
| S105 | 2022-02-18 | 30-day Notice |
| S104 | ||
| S103 | 2020-03-20 | 30-day Notice |
| S102 | 2018-07-05 | 30-day Notice |
| S101 | 2018-05-15 | 30-day Notice |
| S100 | 2017-07-14 | 30-day Notice |
| S099 | 2016-07-21 | Real-time Process |
| S098 | 2016-07-15 | 30-day Notice |
| S097 | 2015-08-03 | 30-day Notice |
| S096 | 2014-09-02 | 30-day Notice |
| S095 | 2014-01-03 | 135 Review Track For 30-day Notice |
| S094 | 2011-10-19 | 135 Review Track For 30-day Notice |
| S093 | 2011-02-08 | 30-day Notice |
| S092 | 2011-01-10 | 30-day Notice |
| S091 | 2008-11-12 | Real-time Process |
| S090 | 2008-09-24 | Real-time Process |
| S089 | 2005-10-18 | Normal 180 Day Track No User Fee |
| S088 | 2001-01-09 | Normal 180 Day Track |
| S087 | 1999-11-16 | Normal 180 Day Track |
| S086 | 1999-10-26 | 30-day Notice |
| S085 | 1997-08-07 | Normal 180 Day Track |
| S084 | 1996-10-01 | Normal 180 Day Track |
| S083 | 1994-11-18 | Normal 180 Day Track |
| S082 | 1993-08-12 | Normal 180 Day Track |
| S081 | 1992-12-01 | Normal 180 Day Track |
| S080 | 1991-11-18 | Normal 180 Day Track |
| S079 | 1991-08-27 | Normal 180 Day Track |
| S078 | ||
| S077 | 1991-06-18 | Normal 180 Day Track |
| S076 | 1991-06-05 | Normal 180 Day Track |
| S075 | 1991-05-10 | Normal 180 Day Track |
| S074 | 1991-05-02 | Normal 180 Day Track |
| S073 | ||
| S072 | ||
| S071 | 1990-11-05 | Normal 180 Day Track |
| S070 | 1990-11-05 | Normal 180 Day Track |
| S069 | 1990-08-23 | Normal 180 Day Track |
| S068 | 1990-07-03 | Normal 180 Day Track |
| S067 | 1990-03-08 | Normal 180 Day Track |
| S066 | 1989-08-29 | Normal 180 Day Track |
| S065 | ||
| S064 | 1989-08-28 | Normal 180 Day Track |
| S063 | 1989-07-24 | Normal 180 Day Track |
| S062 | 1989-07-24 | Normal 180 Day Track |
| S061 | 1989-07-21 | Normal 180 Day Track |
| S060 | 1989-05-25 | Normal 180 Day Track |
| S059 | 1989-01-03 | Normal 180 Day Track |
| S058 | 1988-12-09 | Normal 180 Day Track |
| S057 | 1988-12-09 | Normal 180 Day Track |
| S056 | 1988-12-08 | Normal 180 Day Track |
| S055 | 1988-12-06 | Normal 180 Day Track |
| S054 | 1988-09-20 | Normal 180 Day Track |
| S053 | 1988-08-05 | Special (immediate Track) |
| S052 | 1988-07-29 | Normal 180 Day Track |
| S051 | 1987-10-15 | Normal 180 Day Track |
| S050 | 1987-09-02 | Normal 180 Day Track |
| S049 | 1987-08-06 | 30-Day Supplement |
| S048 | 1987-05-15 | Normal 180 Day Track |
| S047 | 1987-02-02 | 30-Day Supplement |
| S046 | 1987-01-21 | Normal 180 Day Track |
| S045 | 1987-01-05 | Normal 180 Day Track |
| S044 | 1986-08-20 | Normal 180 Day Track |
| S043 | 1986-04-22 | |
| S042 | 1986-03-18 | Normal 180 Day Track |
| S041 | 1986-03-18 | |
| S040 | 1985-08-30 | |
| S039 | ||
| S038 | 1985-03-20 | |
| S037 | 1985-02-07 | |
| S036 | 1984-07-23 | |
| S035 | ||
| S034 | ||
| S033 | 1984-06-22 | |
| S032 | ||
| S031 | 1984-05-08 | |
| S030 | ||
| S029 | 1983-11-14 | |
| S028 | 1983-04-13 | |
| S027 | 1982-12-27 | |
| S026 | 1982-12-16 | |
| S025 | 1982-08-25 | |
| S024 | 1982-07-20 | |
| S023 | 1982-05-20 | |
| S022 | ||
| S021 | 1982-02-19 | |
| S020 | 1981-12-17 | |
| S019 | 1981-10-19 | |
| S018 | 1981-07-29 | |
| S017 | 1981-05-05 | |
| S016 | ||
| S015 | 1980-12-30 | |
| S014 | 1980-09-26 | |
| S013 | 1980-08-25 | |
| S012 | 1980-08-25 | |
| S011 | 1980-08-15 | |
| S010 | 1980-08-01 | |
| S009 | 1980-05-05 | |
| S008 | 1980-04-21 | |
| S007 | 1980-02-05 | |
| S006 | 1979-08-02 | |
| S005 | 1979-07-13 | |
| S004 | 1979-06-06 | |
| S003 | 1979-02-15 | |
| S002 | 1978-12-11 | |
| S001 | 1979-03-02 | Normal 180 Day Track |