Approval for lasik in patients 21 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) from -0. 5 to -13. 0 diopters (d) mrse (manifest refraction spherical equivalence) with or without -0. 5 d to - 4. 0 d astigmatism; and in patients with documented evidence of changes refraction of less than or equal to 0. 5 d (in both cylinder and sphere components) per year for at least one year prior to the date of preoperative examination.
| Device | DISHLER EXCIMER LASER SYSTEMS |
| Applicant | DTC EYE SURGERY CENTER |
| Date Received | 1997-10-06 |
| Decision Date | 1999-12-16 |
| Notice Date | 2001-02-05 |
| PMA | P970049 |
| Supplement | S |
| Docket Number | 01M-0043 |
| Advisory Committee | Neurology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DTC EYE SURGERY CENTER 8400 East Prentice Ave. suite 1200 englewood, CO 80111 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970049 | Original Filing |