The device, as modified, will be marketed under the trade name visx star s3excimer laser system (with eye tracker) and is indicated for phototherapeutic keratectomy (ptk), myopic, astigmatic, and hyperopic (sphere only) photorefractive keratectomy (prk) and myopic and astigmatic laser assisted in-situ keratomileusis (lasik).
| Device | VISX STARR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER) |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | AMO Manufacturing USA, LLC |
| Date Received | 2000-04-12 |
| Decision Date | 2000-04-20 |
| PMA | P930016 |
| Supplement | S011 |
| Product Code | LZS |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | AMO Manufacturing USA, LLC 510 Cottonwood Drive milpitas, CA 95035 |
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 |
NIH GUDID Devices