Premarket Approval (PMA)

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.

• Device: WAVELIGHT EX500 EXCIMER LASER SYSTEM, ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
• Generic Name: Excimer laser system
• Applicant: Alcon Laboratories, Inc.; 6201 S. Freeway; Fort Worth, TX 76134-2099
• PMA Number: P020050
• Supplement Number: S023
• Date Received: 07/20/2015
• Decision Date: 11/21/2016
• Product Code: LZS
• Docket Number: 16M-4046
• Notice Date: 11/30/2016
• Advisory Committee: Ophthalmic
• Clinical Trials: NCT01699087
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: 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