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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
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
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 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