WaveLight EX500 Laser

FDA Premarket Approval P030008 S031

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
PMAP030008
SupplementS031
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
P030008Original Filing
S031 2020-02-25 Normal 180 Day Track
S030 2019-09-16 Real-time Process
S029 2019-07-05 Real-time Process
S028 2019-02-21 Special (immediate Track)
S027 2018-09-26 30-day Notice
S026 2018-05-11 Real-time Process
S025 2018-02-27 Normal 180 Day Track
S024 2018-01-05 Real-time Process
S023 2017-09-28 Real-time Process
S022 2017-03-24 30-day Notice
S021
S020 2015-04-09 30-day Notice
S019 2015-02-27 Real-time Process
S018 2015-02-11 Real-time Process
S017 2015-02-02 Normal 180 Day Track
S016 2014-10-23 Real-time Process
S015 2014-08-14 Normal 180 Day Track
S014 2014-01-29 30-day Notice
S013 2014-01-22 Real-time Process
S012 2013-07-22 Real-time Process
S011 2013-04-17 Special (immediate Track)
S010 2013-01-18 Real-time Process
S009 2012-11-05 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 2005-10-24 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

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