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.
Internally source component assembly and testing services for the model 1125 bed, in addition to externally sourcing this service from the external supplier.
| Device | WaveLight EX500 Excimer Laser System |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | Alcon Laboratories, Inc. |
| Date Received | 2018-09-26 |
| Decision Date | 2018-10-26 |
| PMA | P030008 |
| Supplement | S027 |
| Product Code | LZS |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Alcon Laboratories, Inc. 6201 South Freeway fort Worth, TX 76134-2099 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P030008 | Original Filing | |
| S035 | 2021-09-02 | Real-time Process |
| S034 | 2021-04-12 | Real-time Process |
| S033 | 2021-01-19 | Special (immediate Track) |
| S032 | 2020-12-04 | 30-day Notice |
| S031 | 2020-02-25 | Normal 180 Day Track |
| S030 | 2019-09-16 | Real-time Process |
| S029 | 2019-07-05 | Real-time Process |
| S028 | 2019-02-21 | Special (immediate Track) |
| S027 | 2018-09-26 | 30-day Notice |
| S026 | 2018-05-11 | Real-time Process |
| S025 | 2018-02-27 | Normal 180 Day Track |
| S024 | 2018-01-05 | Real-time Process |
| S023 | 2017-09-28 | Real-time Process |
| S022 | 2017-03-24 | 30-day Notice |
| S021 | ||
| S020 | 2015-04-09 | 30-day Notice |
| S019 | 2015-02-27 | Real-time Process |
| S018 | 2015-02-11 | Real-time Process |
| S017 | 2015-02-02 | Normal 180 Day Track |
| S016 | 2014-10-23 | Real-time Process |
| S015 | 2014-08-14 | Normal 180 Day Track |
| S014 | 2014-01-29 | 30-day Notice |
| S013 | 2014-01-22 | Real-time Process |
| S012 | 2013-07-22 | Real-time Process |
| S011 | 2013-04-17 | Special (immediate Track) |
| S010 | 2013-01-18 | Real-time Process |
| S009 | 2012-11-05 | Normal 180 Day Track |
| S008 | 2012-07-30 | Real-time Process |
| S007 | 2012-03-12 | 30-day Notice |
| S006 | 2011-04-04 | Normal 180 Day Track |
| S005 | 2006-12-19 | Normal 180 Day Track |
| S004 | 2005-10-24 | Panel Track |
| S003 | 2005-04-01 | Normal 180 Day Track |
| S002 | 2005-01-31 | Real-time Process |
| S001 | 2004-05-21 | Normal 180 Day Track No User Fee |