WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
Trade Name
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
Classification Name
excimer laser system
Generic Name
excimer laser system
Applicant
ALCON LABORATORIES, INC.
PMA Number
P020050
Date Received
11/20/2002
Decision Date
10/07/2003
Product Code
LZS
Docket Number
03M-0491
Date Notice
10/28/2003
Advisory Committee
Ophthalmic
Expedited Review Granted?
No
Information About:
Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement
Approval for the wavelight allegretto wave excimer laser system. The device used optical zones of 6. 0 and 6. 5 mm with an ablation/treatment zone up to 9. 0 mm, and s indicated for laser assisted in situ keratomileusis (lasik): 1) for the reduction or elimination of myopia of up to -12. 0 diopters (d) of sphere and up to -6. 0 d of astigmatism at the spectacle plane; 2) in patients who are 18 years of age or older; and 3) in patients with documentation of a stable manifest refraction defined as <=0. 50d of preoperative spherical equivalent shift over one year prior to surgery.
