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 an increase of the pulse repetition frequency from the present value (200 hz. ) to 300 hz.
| Device | LSX EXCIMER LASER SYSTEM |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | LASERSIGHT TECHNOLOGIES, INC. |
| Date Received | 2002-10-31 |
| Decision Date | 2002-12-16 |
| PMA | P980008 |
| Supplement | S012 |
| 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 | LASERSIGHT TECHNOLOGIES, INC. 6903 University Blvd., winter Park, FL 32792 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P980008 | Original Filing | |
| S012 | 2002-10-31 | Real-time Process |
| S011 | ||
| S010 | ||
| S009 | 2001-10-26 | Special (immediate Track) |
| S008 | 2001-10-05 | Real-time Process |
| S007 | ||
| S006 | ||
| S005 | 2000-12-19 | Panel Track |
| S004 | ||
| S003 | 2000-07-20 | Real-time Process |
| S002 | 2000-07-13 | Normal 180 Day Track |
| S001 |