Approval to upgrade the software and hardware to its combined corneal topographer and wavefront aberrometry device, the idesign advanced wavescan studio system, and expansion of the indications for use of the idesign system, in combination with the star s4 ir excimer laser systems, to include the monovision treatment of myopic presbyopes. The device, as modified, will be marketed under the trade name idesign refractive studio, star excimer laser system and is indicated for wavefront-guided laser assisted in situ keratomileusis (lasik) to achieve monovision by the targeted retention of myopia (-1. 25 to -2. 00 d) in the non-dominant 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 spherical equivalent as measured by idesign® refractive studio, with cylinder up to -3. 00 d, and a minimum pre-operative myopia in their non-dominant eye at least as great as their targeted myopia; 3) with an agreement between manifest refraction (adjusted for optical infinity) and idesign® refractive studio refraction as follows: a. Spherical equivalent: magnitude of the difference is less than 0. 625 d. B. Cylinder: magnitude of the difference is less than or equal to 0. 5 d. C. Cylinder axis: if either the manifest cylinder entered into the idesign® refractive studio or the idesign® refractive studio cylinder selected for treatment is less than 0. 5 d, there is no requirement for axis tolerance. When both cylinders have a magnitude of at least 0. 5 d, the axis tolerance is linearly reduced from 15>= (0. 5 d) to 7. 5 >= (7. 0 d or greater) based on the average magnitude of both cylinders;4) with documented evidence of a change in manifest refraction of no more than +0. 5 d (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination; and 5) with a successful preoperative trial of monovision or history of monovision experience.
| Device | iDESIGNRefractive Studio, STAR Excimer Laser System |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | AMO Manufacturing USA, LLC |
| Date Received | 2017-09-29 |
| Decision Date | 2018-06-15 |
| PMA | P930016 |
| Supplement | S053 |
| 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 | AMO Manufacturing USA, LLC 510 Cottonwood Drive milpitas, CA 95035 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
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