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 the lasersight laserscan lsx excimer laser system for laser-assisted in situ keratomileusis (lasik). The device is indicated for lasik: 1) for the reduction or elimination of myopia ranging from -0. 5 to less than -6. 0 diopters (d) spherical equivalent, with astigmatism less than or equal to 4. 5 d, as measured at the spectacle plane; 2) in patients with documentation of a stable manifest refraction defined as
| Device | LASERSIGHT LASERSCAN LSX EXCIMER LASER SYSTEM FOR LASER-ASSITED IN SITU KERATOMILEUSIS (LASIK) |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | LASERSIGHT TECHNOLOGIES, INC. |
| Date Received | 2000-12-19 |
| Decision Date | 2001-09-28 |
| Notice Date | 2001-10-26 |
| PMA | P980008 |
| Supplement | S005 |
| Product Code | LZS |
| Docket Number | 01M-0490 |
| Advisory Committee | Ophthalmic |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | LASERSIGHT TECHNOLOGIES, INC. 6903 University Blvd., winter Park, FL 32792 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| 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 |