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Device | LASERSCAN LSX EXCIMER LASER SYSTEM |
Generic Name | Excimer laser system |
Applicant | LASERSIGHT TECHNOLOGIES, INC. 6903 UNIVERSITY BLVD., WINTER PARK, FL 32792 |
PMA Number | P980008 |
Date Received | 03/19/1998 |
Decision Date | 11/12/1999 |
Product Code |
LZS |
Docket Number | 00M-1231 |
Advisory Committee |
Ophthalmic |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S002 S003 S005 S008 S009 S012 |