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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.
 
Trade NameALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
ApplicantALCON LABORATORIES, INC.
PMA NumberP020050
Supplement NumberS012
Date Received04/03/2013
Decision Date09/27/2013
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 13M-1321
Notice Date 10/30/2013
Advisory Committee Ophthalmic
Clinical Trials NCT01028378
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 allegretto wave® eye-q 400hz excimer laser system. This device is indicated for the following: the wavelight allegretto wave® eye-q excimer laser system used in conjunction with the wavelight allegro topolyzer (topographer) and t-cat treatment planning software is indicated for performing topography-guided laser assisted in situ keratomileusis (topo-guided (t-cat) lasik): 1) for the reduction or elimination of up to -9. 00 diopters (d) of spherical equivalent myopia or myopia with astigmatism, with up to -8. 00 d of spherical component and up to -3. 00d 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. 50d or less of preoperative spherical equivalent shift over one year prior to surgery. ¿.
Approval Order Approval Order
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