SVS APEX EXCIMER LASER SYSTEM
Trade Name
SVS APEX EXCIMER LASER SYSTEM
Classification Name
excimer laser system
Applicant
ALCON LABORATORIES, INC.
PMA Number
P930034
Date Received
10/12/1993
Decision Date
10/20/1995
Product Code
LZS
Docket Number
96M-0274
Date Notice
08/15/1996
Advisory Committee
Ophthalmic
Expedited Review Granted?
No
Approval Order Statement
Indicated for a 6. 0 mm ablation zone, myopic photorefractive keratectomy (prk) in patients who meet all of the following criteria:1)1. 5 to 7. 0 diopters of myopia with astigmatism of <- 1. 5 diopters; 2)refraction is within +- 1. 0 diopter for one year prior tot he laser treatment; and 3) 21 years of age or older x.
