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 a change to the quality control process that will extend the beam repeatability test from 2 to 8 hours to more accurately resemble actual field use.
| Device | LASERSCAN LSX EXCIMER LASER SYSTEM |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | LASERSIGHT TECHNOLOGIES, INC. |
| Date Received | 2001-10-26 |
| Decision Date | 2001-11-09 |
| PMA | P980008 |
| Supplement | S009 |
| Product Code | LZS |
| Advisory Committee | Ophthalmic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |