Approval for the upgrade wavescan wavefront system software version 3. 90. The device, as modified, will be marketed under the trade names star s4 ir excimer laser system with variable spot scanning (vss) wavescan wavefront system and are indicated for wavefront-guided (wrg) laser assisted in situ keratomileusis (lasik) to achieve eye of presbyopic myopes: 1) 40 years or older who may benefit from increased spectacle independence across a range of distances with useful near vision; 2) with myopic astigmatism up to -6. 00 d mrse, with cylinder up to -3. 00 d, and minimum pre-operative myopia in their non-dominant eye at least as great as their targeted myopia; 3) with documented evidence of a change in manifest refraction of no more than 0. 50 d (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination; and 4) with a successful preoperative trial of monovision or history of monovision experience.
Device | STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) WAVESCAN WAVEFRONT SYSTEM |
Classification Name | Excimer Laser System |
Generic Name | Excimer Laser System |
Applicant | AMO Manufacturing USA, LLC |
Date Received | 2007-11-21 |
Decision Date | 2008-01-16 |
PMA | P930016 |
Supplement | S030 |
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