ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM

Excimer Laser System

FDA Premarket Approval P020050 S012

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.

Pre-market Approval Supplement Details

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. ¿

• Device: ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
• Classification Name: Excimer Laser System
• Generic Name: Excimer Laser System
• Applicant: Alcon Laboratories, Inc.
• Date Received: 2013-04-01
• Decision Date: 2013-09-27
• Notice Date: 2013-10-30
• PMA: P020050
• Supplement: S012
• Product Code: LZS
• Docket Number: 13M-1321
• Advisory Committee: Ophthalmic
• Supplement Type: Panel Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: Alcon Laboratories, Inc. 6201 South Freeway fort Worth, TX 76134-2099
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling Labeling Part 2
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P020050		Original Filing
S039	2021-09-02	Real-time Process
S038	2021-04-12	Real-time Process
S037	2021-01-19	Special (immediate Track)
S036	2020-12-04	30-day Notice
S035	2020-02-25	Normal 180 Day Track
S034	2019-09-16	Real-time Process
S033	2019-07-05	Real-time Process
S032	2019-02-21	Special (immediate Track)
S031	2018-09-26	30-day Notice
S030	2018-05-11	Real-time Process
S029	2018-02-27	Normal 180 Day Track
S028	2018-01-05	Real-time Process
S027	2017-09-28	Real-time Process
S026	2017-03-24	30-day Notice
S025
S024	2015-07-29	Real-time Process
S023	2015-07-20	Panel Track
S022	2015-04-09	30-day Notice
S021	2015-02-27	Real-time Process
S020	2015-02-11	Real-time Process
S019	2015-02-02	Normal 180 Day Track
S018	2014-10-23	Real-time Process
S017	2014-08-14	Normal 180 Day Track
S016	2014-01-29	30-day Notice
S015	2014-01-22	Real-time Process
S014	2013-07-22	Real-time Process
S013	2013-04-17	Special (immediate Track)
S012	2013-04-01	Panel Track
S011	2013-01-18	Real-time Process
S010	2012-11-05	Normal 180 Day Track
S009	2012-09-04	Normal 180 Day Track
S008	2012-07-30	Real-time Process
S007	2012-03-12	30-day Notice
S006	2011-04-04	Normal 180 Day Track
S005	2006-12-19	Normal 180 Day Track
S004	2006-01-30	Panel Track
S003	2005-04-01	Normal 180 Day Track
S002	2005-01-31	Real-time Process
S001	2004-05-21	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
00380659907944	P020050	000
00380659907463	P020050	006
00380659907678	P020050	009
00380659908170	P020050	014
00380659908163	P020050	014
00380659908965	P020050	015
00380650001108	P020050	015