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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Alcon Laboratories, Inc.
6201 south freeway
fort worth, TX 76134-2099
PMA NumberP020050
Supplement NumberS004
Date Received01/30/2006
Decision Date07/26/2006
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 06M-0325
Notice Date 08/17/2006
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the wavelight allegretto wave excimer laser system used in conjunction with the wavelight allegro analyzer. The device uses a 6. 5 mm optical zone, a 9. 0 mm ablation/treatment zone, and is indicated for wavefront-guided (wfg) laser assisted in situ keratomileusis (lasik): 1) for the reduction or elimination of up to -7. 00 diopters (d) of spherical equivalent myopia or myopia with astigmatism, with up to -7. 00 d of spherical component and up to 3. 00 d of astigmatic component 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. 50 d of preoperative spherical equivalent shift over one year prior to surgery.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2