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Device | DISHLER EXCIMER LASER SYSTEMS |
Applicant | DTC EYE SURGERY CENTER 8400 EAST PRENTICE AVE. SUITE 1200 ENGLEWOOD, CO 80111 |
PMA Number | P970049 |
Date Received | 10/06/1997 |
Decision Date | 12/16/1999 |
Withdrawal Date
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04/11/2002 |
Docket Number | 01M-0043 |
Notice Date | 02/05/2001 |
Advisory Committee |
Neurology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
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