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 a new software release for the wavelight® ex500 excimer laser system (model 1016-3), wavenet planning software (wps) - standalone software. (model 6164), and allegro topolyzer vario - topographer (model 1028) the devices, as modified, will continue to be marketed under the trade names wavelight® ex500 excimer laser system - excimer laser system (model 1016-3), wavenet planning software (wps) - standalone software. (model 6164), and allegro topolyzer vario - topographer (model 1028).
| Device | WAVELIGHT EX500 LASER SYSTEM |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | Alcon Laboratories, Inc. |
| Date Received | 2015-02-27 |
| Decision Date | 2015-06-02 |
| PMA | P030008 |
| Supplement | S019 |
| Product Code | LZS |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |