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: 1) an increase in the laser pulse repetition frequency from the current 50 hz to 100 hz; 2)replacement of the ceratube midi v. 4. 1 laser with the ceratube midi v. 5. 2 laser; 3) software revisions to accommodate the new laser and pulse rate; 4) labeling changes to document these modifications.
| Device | BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | TECHNOLAS PERFECT VISION GMBH |
| Date Received | 2004-09-10 |
| Decision Date | 2006-03-15 |
| PMA | P990027 |
| Supplement | S007 |
| Product Code | LZS |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| 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 |