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 visx excimer laser system (models b & c)
| Device | VISX MODELB/MODEL C EXCIMER LASER SYSTEM |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | AMO Manufacturing USA, LLC |
| Date Received | 1991-10-16 |
| Decision Date | 1995-09-29 |
| Notice Date | 1996-12-23 |
| PMA | P910062 |
| Supplement | S |
| Product Code | LZS |
| Docket Number | 96M-0486 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | AMO Manufacturing USA, LLC 510 Cottonwood Drive milpitas, CA 95035 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P910062 | Original Filing | |
| S008 | 2018-12-31 | Real-time Process |
| S007 | 2014-07-07 | Real-time Process |
| S006 | 2014-05-19 | 30-day Notice |
| S005 | ||
| S004 | 2014-05-01 | 30-day Notice |
| S003 | ||
| S002 | ||
| S001 | 2000-04-12 | Real-time Process |