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.
The device, as modified, will be marketed under the trade name visx star s3 excimer laser system (with eye tracker) and is indicated for phototherapeutic keratectomy (ptk), myopic, astigmatic, and hyperopic (sphere only) photorefractive keratectomy (prk) and myopic and astigmatic laser assisted in-situ keratomileusis (lasik).
| Device | VISX STAR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER) |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | AMO Manufacturing USA, LLC |
| Date Received | 2000-04-12 |
| Decision Date | 2000-04-20 |
| PMA | P990010 |
| Supplement | S001 |
| Product Code | LZS |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| 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 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990010 | 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 |