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.
Addition of a re-polishing process for the hex prism assembly, of the star system.
| Device | STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | AMO Manufacturing USA, LLC |
| Date Received | 2014-05-19 |
| Decision Date | 2014-05-30 |
| PMA | P910062 |
| Supplement | S006 |
| Product Code | LZS |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |