Premarket Approval (PMA)

Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.

• Trade Name: WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
• Classification Name: excimer laser system
• Generic Name: excimer laser system
• Applicant: ALCON LABORATORIES, INC.
• PMA Number: P030008
• Date Received: 03/19/2003
• Decision Date: 10/10/2003
• Product Code: LZS [ Registered Establishments with LZS ]
• Docket Number: 03M-0492
• Notice Date: 10/28/2003
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: 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.

Approval Order

Approval Order

• Supplements: S001 S002 S003 S004 S005 S006 ; S007 S008 S010 S011