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 wavelight allegretto wave excimer laser system. The devices uses optical zones of 6. 0 and 6. 5 mm with an ablation/treatment zone up to 9. 0 mm, and is indicated for laser assisted in situ keratomileusis (lasik): 1) for the reduction or elimination of hyperopic refractive errors up to +6. 0 diopters (d) of sphere with and without astigmatic refractive errors up to 5. 0 d at the spectacle plane, with a maximum manifest refraction spherical equivalent (mrse) of +6. 0 d; 2) in patients who are 18 years of age or older; and 3) in patients with documentation of a stable manifest refraction defined as
| Device | WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | Alcon Laboratories, Inc. |
| Date Received | 2003-03-19 |
| Decision Date | 2003-10-10 |
| Notice Date | 2003-10-28 |
| PMA | P030008 |
| Supplement | S |
| Product Code | LZS |
| Docket Number | 03M-0492 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Alcon Laboratories, Inc. 6201 South Freeway fort Worth, TX 76134-2099 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| 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 |