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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Nameexcimer laser system
Generic Nameexcimer laser system
PMA NumberP030008
Date Received03/19/2003
Decision Date10/10/2003
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 S009 
S010 S011 S012 S013 S014