Approval for increased pulse frequency from 400 to 500 hz, a new laser head, a new housing with greater integration of accessories, modified laser pulse temporal parameters, new eyetracker, new scanner, remodeled user interface, addition of networking capability, andmodified software. The device, as modified, will be marketed under the trade name wavelight ex500 laser system and is indicated for laser assisted in situ keratomileusis (lasik) for:1) the reduction or elimination of myopia of up to -12. 0 diopters (d) of sphere and up to - 6. 0 d of astigmatism at the spectacle plane in patients who are 18 years of age or older with documentation of a stable manifest refraction defined as
| Device | WAVELIGHT EX500 LASER SYSTEM |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | Alcon Laboratories, Inc. |
| Date Received | 2011-04-04 |
| Decision Date | 2011-11-23 |
| PMA | P020050 |
| Supplement | S006 |
| Product Code | LZS |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| 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 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P020050 | | Original Filing |
| S039 |
2021-09-02 |
Real-time Process |
| S038 |
2021-04-12 |
Real-time Process |
| S037 |
2021-01-19 |
Special (immediate Track) |
| S036 |
2020-12-04 |
30-day Notice |
| S035 |
2020-02-25 |
Normal 180 Day Track |
| S034 |
2019-09-16 |
Real-time Process |
| S033 |
2019-07-05 |
Real-time Process |
| S032 |
2019-02-21 |
Special (immediate Track) |
| S031 |
2018-09-26 |
30-day Notice |
| S030 |
2018-05-11 |
Real-time Process |
| S029 |
2018-02-27 |
Normal 180 Day Track |
| S028 |
2018-01-05 |
Real-time Process |
| S027 |
2017-09-28 |
Real-time Process |
| S026 |
2017-03-24 |
30-day Notice |
| S025 | | |
| S024 |
2015-07-29 |
Real-time Process |
| S023 |
2015-07-20 |
Panel Track |
| S022 |
2015-04-09 |
30-day Notice |
| S021 |
2015-02-27 |
Real-time Process |
| S020 |
2015-02-11 |
Real-time Process |
| S019 |
2015-02-02 |
Normal 180 Day Track |
| S018 |
2014-10-23 |
Real-time Process |
| S017 |
2014-08-14 |
Normal 180 Day Track |
| S016 |
2014-01-29 |
30-day Notice |
| S015 |
2014-01-22 |
Real-time Process |
| S014 |
2013-07-22 |
Real-time Process |
| S013 |
2013-04-17 |
Special (immediate Track) |
| S012 |
2013-04-01 |
Panel Track |
| S011 |
2013-01-18 |
Real-time Process |
| S010 |
2012-11-05 |
Normal 180 Day Track |
| S009 |
2012-09-04 |
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 |
2006-01-30 |
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 |
NIH GUDID Devices