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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 NumberP030008
Supplement NumberS004
Date Received10/24/2005
Decision Date04/19/2006
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 06M-0199
Notice Date 05/12/2006
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. The device used optical zones of 6. 0-7. 0 mm with an ablation/treatment zone up to 9. 0 mm, and is indicated for laser assisted in situ keratomileusis (lasik) for: 1) the reduction or elimination of naturally occurring mixed astigmatism of up to 6. 00 diopters (d) at the spectacle plane; 2) patients who are 21 years of age or older; and 3) patients with documentation of a stable manifest refraction defined as <= 0. 50 d 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