This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the technolas(r) 217a excimer laser system. The devices is indicated to perform laser in-situ keratomileusis (lasik): 1) in treatments for the reduction or eliminatino of myopia (nearsightedness) from -1. 00 to -7. 00 diopters d with less than -3. 00 d astigmatism; 2) in patients with documented stability of refraction for the prior 12 months as demonstrated by a change in manifest refraction of less than or equal to 0. 5 d (in both cylinder and sphere components); and, 3) in patients 21 years of age or older.
| Device | TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z) |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | TECHNOLAS PERFECT VISION GMBH |
| Date Received | 1999-05-28 |
| Decision Date | 2000-02-23 |
| Notice Date | 2000-11-03 |
| PMA | P990027 |
| Supplement | S |
| Product Code | LZS |
| Docket Number | 00M-1597 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | TECHNOLAS PERFECT VISION GMBH messerschmittstr 1 + 3 munchen 80992 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| 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 |