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 to expand the approval of the topolyzer vario to include its use as a diagnostic device supporting the wavelight excimer lasers in performing t-cat lasik. The device, as modified, will be marketed under the trade name allegro topolyzer vario and is indicated for the wavelight allegretto wave® eye-q excimer laser system used in conjunction with the wavelight allegro topolyzer (topographer) or allegro topolyzer vario (topographer) and t-cat treatment planning software is indicated for performing topography-guided laser assisted in situ keratomileusis (topo-guided (t-cat) lasik):1) for the reduction or elimination of up to -9. 00 diopters (d) of spherical equivalent myopia or myopia with astigmatism, with up to -8. 00 d of spherical component and up to -3. 00 d of astigmatic component at the spectacle plane;2) in patients who are 18 years of age or older; and3) in patients with documentation of a stable manifest refraction defined as 0. 50 d or less of preoperative spherical equivalent shift over one year prior to surgery.
| Device | ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | Alcon Laboratories, Inc. |
| Date Received | 2015-02-02 |
| Decision Date | 2015-05-01 |
| PMA | P030008 |
| Supplement | S017 |
| 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 |
| 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 |