Approval for four edits in engineering drawing of "beam splitter, energy detector'' and change of the material in the beam splitter component of the energy detector from corning fused silica code 7940 to corning 7980 hpfs.
| Device | STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | AMO Manufacturing USA, LLC |
| Date Received | 2018-12-31 |
| Decision Date | 2019-04-12 |
| PMA | P930016 |
| Supplement | S056 |
| 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