Approval for the visx excimer laser system (models b and c). This device is indicated for myopic and astigmatic prk using an ablation zone with a 6. 0 mm major axis. The prk procedure is intended for use: 1)in patients with documented evidence of a change in manifest refraction of less than or equal to 0. 5d (in both cylinder and sphere components) per year for at least one year prior to the date of the pre-operative examination; and 2) in patients 18-20 years of age in prk treatments for the reduction or elimination of myopia (nearsightedness) of less than or equal to -6. 0 d spherical equivelent at the corneal plane with less than or equal to -1. 0 d of astigmatism; or 3) in patients 21 years of age or older in prk treatments for the reduction or elimination of myopia (nearsightedness) of between 0 and -12. 0 d spherical myopia at the spectacle plane and up to -4. 0 d of astigmatism.
| Device | VISX EXCIMER LASER SYSTEM MODELS B AND C |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | AMO Manufacturing USA, LLC |
| Date Received | 1997-07-23 |
| Decision Date | 1998-01-29 |
| Notice Date | 1999-07-15 |
| PMA | P930016 |
| Supplement | S005 |
| Product Code | LZS |
| Docket Number | 99M-0293 |
| Advisory Committee | Ophthalmic |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | AMO Manufacturing USA, LLC 510 Cottonwood Drive milpitas, CA 95035 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P930016 | | Original Filing |
| S062 |
2020-10-01 |
Normal 180 Day Track No User Fee |
| S061 |
2019-11-25 |
Real-time Process |
| S060 |
2019-10-31 |
Real-time Process |
| S059 |
2019-03-29 |
Normal 180 Day Track No User Fee |
| S058 |
2019-01-22 |
Real-time Process |
| S057 | | |
| S056 |
2018-12-31 |
Real-time Process |
| S055 |
2018-07-16 |
Normal 180 Day Track No User Fee |
| S054 |
2017-12-01 |
Real-time Process |
| S053 |
2017-09-29 |
Normal 180 Day Track |
| S052 |
2017-06-12 |
30-day Notice |
| S051 |
2017-05-16 |
Real-time Process |
| S050 |
2017-03-16 |
30-day Notice |
| S049 |
2016-12-27 |
30-day Notice |
| S048 |
2016-12-01 |
Panel Track |
| S047 |
2015-11-17 |
Real-time Process |
| S046 |
2015-10-19 |
Real-time Process |
| S045 |
2015-06-01 |
Panel Track |
| S044 |
2014-11-10 |
Panel Track |
| S043 |
2014-07-07 |
Real-time Process |
| S042 |
2014-05-19 |
30-day Notice |
| S041 | | |
| S040 |
2014-05-01 |
30-day Notice |
| S039 | | |
| S038 |
2013-05-28 |
Special (immediate Track) |
| S037 | | |
| S036 |
2011-10-28 |
30-day Notice |
| S035 |
2011-08-29 |
Normal 180 Day Track |
| S034 |
2010-09-20 |
Normal 180 Day Track |
| S033 | | |
| S032 |
2009-09-18 |
Normal 180 Day Track |
| S031 |
2008-08-11 |
Normal 180 Day Track |
| S030 |
2007-11-21 |
Real-time Process |
| S029 | | |
| S028 |
2007-10-29 |
Normal 180 Day Track No User Fee |
| S027 |
2007-08-08 |
Normal 180 Day Track |
| S026 |
2006-10-24 |
Real-time Process |
| S025 |
2006-09-29 |
Panel Track |
| S024 |
2006-03-30 |
Real-time Process |
| S023 |
2005-08-12 |
Real-time Process |
| S022 |
2005-03-30 |
Real-time Process |
| S021 |
2005-03-08 |
Panel Track |
| S020 |
2004-09-21 |
Panel Track |
| S019 |
2004-09-07 |
Normal 180 Day Track |
| S018 | | |
| S017 |
2003-11-28 |
Panel Track |
| S016 |
2002-10-01 |
Panel Track |
| S015 |
2002-07-30 |
Real-time Process |
| S014 |
2001-06-04 |
Panel Track |
| S013 |
2001-02-05 |
Normal 180 Day Track |
| S012 |
2000-07-14 |
Panel Track |
| S011 |
2000-04-12 |
Real-time Process |
| S010 |
1999-06-18 |
Panel Track |
| S009 | | |
| S008 | | |
| S007 |
1998-03-05 |
Panel Track |
| S006 |
1998-02-26 |
Real-time Process |
| S005 |
1997-07-23 |
Panel Track |
| S004 |
1996-12-17 |
Normal 180 Day Track |
| S003 |
1996-08-26 |
Panel Track |
| S002 |
1996-05-16 |
Normal 180 Day Track |
| S001 |
1996-04-18 |
Normal 180 Day Track |
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