This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for the advanced nomogram software module as an upgrade to the existing software of the technolas perfect vision® 217z zyoptix system for personalized vision correction. The advanced nomogram resides on a separate computer with the zylink treatmentcalculation software, and it leaves all hardware components and the laser beam control software module unchanged. The technolas perfect vision 217z zyoptix system for personalizedvision correction with advanced nomogram software module is indicated for wavefront-guidedlaser assisted in-situ keratomileusis (lasik):1) for the reduction or elimination of myopia with sphere up to -7. 00 d and cylinder up to-3. 00 d and mrse
| Device | TECHNOLAS PERFECT VISION 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | TECHNOLAS PERFECT VISION GMBH |
| Date Received | 2010-06-29 |
| Decision Date | 2010-11-30 |
| PMA | P990027 |
| Supplement | S015 |
| 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 | TECHNOLAS PERFECT VISION GMBH messerschmittstr 1 + 3 munchen 80992 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990027 | Original Filing | |
| S020 | 2015-10-07 | 30-day Notice |
| S019 | 2014-01-31 | 30-day Notice |
| S018 | 2012-05-01 | Normal 180 Day Track |
| S017 | 2012-04-26 | Real-time Process |
| S016 | 2010-09-17 | 135 Review Track For 30-day Notice |
| S015 | 2010-06-29 | Normal 180 Day Track |
| S014 | ||
| S013 | 2009-10-01 | Real-time Process |
| S012 | 2009-05-15 | Normal 180 Day Track No User Fee |
| S011 | 2008-09-03 | Normal 180 Day Track |
| S010 | 2008-08-11 | Normal 180 Day Track |
| S009 | 2006-12-19 | Normal 180 Day Track |
| S008 | ||
| S007 | 2004-09-10 | Normal 180 Day Track |
| S006 | 2002-07-18 | Panel Track |
| S005 | 2002-01-31 | Normal 180 Day Track |
| S004 | 2001-12-14 | Panel Track |
| S003 | 2001-04-27 | Normal 180 Day Track |
| S002 | 2000-11-24 | Panel Track |
| S001 | 2000-10-13 | Normal 180 Day Track |