WaveLight EX500 Laser

FDA Premarket Approval P020050 S035

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 software changes on the wavelight® ex500 and the associated wavenet™ planning software (wps) to include enhanced wavefront optimized (ewfo) treatment with finer adjustment steps for targeted refraction and targeted optical zone

DeviceWaveLight EX500 Laser
Generic NameExcimer Laser System
ApplicantAlcon Laboratories, Inc.
Date Received2020-02-25
Decision Date2020-08-21
PMAP020050
SupplementS035
Product CodeLZS 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
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
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 IDPMASupp
00380659907944 P020050 000
00380659907944 P020050 000
00380659907463 P020050 006
00380659907463 P020050 006
00380659907678 P020050 009
00380659907678 P020050 009
00380659908163 P020050 014
00380659908170 P020050 014
00380659908170 P020050 014
00380659908163 P020050 014
00380659908965 P020050 015
00380659908965 P020050 015

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