WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
Trade Name
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
Classification Name
excimer laser system
Generic Name
ophthalmic medical laser system (193 nanometer wavelength)
Applicant
ALCON LABORATORIES, INC.
PMA Number
P030008
Date Received
03/19/2003
Decision Date
10/10/2003
Product Code
LZS
Docket Number
03M-0492
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 devices uses optical zones of 6. 0 and 6. 5 mm with an ablation/treatment zone up to 9. 0 mm, and is indicated for laser assisted in situ keratomileusis (lasik): 1) for the reduction or elimination of hyperopic refractive errors up to +6. 0 diopters (d) of sphere with and without astigmatic refractive errors up to 5. 0 d at the spectacle plane, with a maximum manifest refraction spherical equivalent (mrse) of +6. 0 d; 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. 50 d of preoperative spherical equivalent shift over one year prior to surgery, exclusive of changes due to unmasking latent hyperopia.
