Approval for a single laser, kremer excimer laser system serial no. Kea940202. This device, using a 6. 0 mm ablation zone, is indicated for myopic and astigmatic laser in situ keratomileusis (lasik) in patients: 1)with myopia ranging between -1. 0 and -15. 0 diopters (d) with or without astigmatism ranging from 0. 0 d to 5. 00 d; 2) who are 18 years of age or older; and 3) with stable refraction over the 1-year period prior to surgery. Note: patients between 18 and 20 years old should not demonstrate a shift in refraction greater than 0. 5d. Patients 21 years and older should not demonstrate a shift greater than 1. 0 d.
| Device | KREMER LASER SYSTEM |
| Generic Name | Excimer Laser System |
| Applicant | LASERSIGHT TECHNOLOGIES, INC. |
| Date Received | 1997-01-31 |
| Decision Date | 1998-07-30 |
| PMA | P970005 |
| Supplement | S |
| Product Code | LZS |
| Docket Number | 00M-0811 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | LASERSIGHT TECHNOLOGIES, INC. 6848 Stapoint Court winter Park, FL 32792 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970005 | Original Filing |