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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceWAVELIGHT EX500 EXCIMER LASER SYSTEM, ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
Alcon Laboratories, Inc.
6201 south freeway
fort worth, TX 76134-2099
PMA NumberP020050
Supplement NumberS023
Date Received07/20/2015
Decision Date11/21/2016
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 16M-4046
Notice Date 11/30/2016
Advisory Committee Ophthalmic
Clinical Trials NCT01699087
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 EX500 Excimer Laser System and Allegretto Wave Eye-Q Excimer Laser System. These devices are indicated for use in Photorefractive Keratectomy (PRK) treatments for: 1) the reduction or elimination of up to -6.0 diopters (D) of spherical equivalent myopia or myopia with astigmatism, with up to -6.0 D of spherical component and up to -3.0 D of astigmatic component at the spectacle plane;2) patients who are 18 years of age or older; and 3) patients with documentation of a stable manifest refraction defined as <=0.5 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
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