LADARVISION EXCIMER LASER SYSTEM
Trade Name
LADARVISION EXCIMER LASER SYSTEM
Classification Name
excimer laser system
Generic Name
tracker assisted excimer laser system
Applicant
ALCON LABORATORIES
PMA Number
P970043
Date Received
09/05/1997
Decision Date
11/02/1998
Product Code
LZS
Docket Number
00M-1592
Date Notice
02/05/2001
Advisory Committee
Ophthalmic
Expedited Review Granted?
No
Information About:
Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement
Indicated for use in photorefractive keratectomy (prk) treatment for the reduction or elimination of mild to moderate myopia in patients with the following three characteristics: 1) between -1. 00d to -10. 00d of sphere and less than or equal to -4. 00d of astigmatism at the spectacle plane, the combination of which must result in an attempted correction between -0. 50d and -10. 00d spherical equivalent (se) at the spectacle plane where sphere or cylinder is at least 1. 00d; 2) who are 21 years of age or older; and 3) with documented stability of refraction for the prior 12 months, as demonstrated by a change of less than or equal to 0. 50d for corrections up to -7. 00d se, and less than or equal to -1. 00d for corrections greater than -7. 00 d se.
