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 | ALLEGRO TOPOLYZER VARIO |
| 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 | P020050 |
| Supplement | S019 |
| 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