WaveLlght EX500 Laser System

FDA Premarket Approval P030008 S033

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 labeling changes to add and strengthen contraindications

DeviceWaveLlght EX500 Laser System
Generic NameExcimer Laser System
ApplicantAlcon Laboratories, Inc.
Date Received2021-01-19
Decision Date2021-02-18
PMAP030008
SupplementS033
Product CodeLZS 
Advisory CommitteeOphthalmic
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
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
S033 2021-01-19 Special (immediate Track)
S032 2020-12-04 30-day Notice
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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