|
Device | WAVELIGHT EX500 EXCIMER LASER SYSTEM, ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM |
Generic Name | Excimer laser system |
Applicant | Alcon Laboratories, Inc. 6201 South 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 |
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 |