This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the laserscan lsx excimer laser system. The device is indicated for myopic photorefractive keratectomy: for the reduction or elimination of myopia ranging from -1. 0 to less than -6. 0 diopters (d) with less than or equal to 1. 0 d of astigmatism; in patients with documentation of a stable manifest refraction (+-0. 5d) over the prior one year; and in patients who are 18 years of age or older.
| Device | LASERSCAN LSX EXCIMER LASER SYSTEM |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | LASERSIGHT TECHNOLOGIES, INC. |
| Date Received | 1998-03-19 |
| Decision Date | 1999-11-12 |
| PMA | P980008 |
| Supplement | S |
| Product Code | LZS |
| Docket Number | 00M-1231 |
| Advisory Committee | Ophthalmic |
| 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 |