WaveLight EX500 Laser System

FDA Premarket Approval P020050 S039

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 a hardware design change to the wavelight ex500 laser (p020050 and p030008).

DeviceWaveLight EX500 Laser System
Generic NameExcimer Laser System
ApplicantAlcon Laboratories, Inc.
Date Received2021-09-02
Decision Date2021-11-19
Product CodeLZS 
Advisory CommitteeOphthalmic
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Alcon Laboratories, Inc. 6201 South Freeway fort Worth, TX 76134-2099

Supplemental Filings

Supplement NumberDateSupplement Type
P020050Original 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
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


Device IDPMASupp
00380659907944 P020050 000
00380659907463 P020050 006
00380659907678 P020050 009
00380659908170 P020050 014
00380659908163 P020050 014
00380659908965 P020050 015
00380650001108 P020050 015

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