ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM

Excimer Laser System

FDA Premarket Approval P030008 S017

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 to expand the approval of the topolyzer vario to include its use as a diagnostic device supporting the wavelight excimer lasers in performing t-cat lasik. The device, as modified, will be marketed under the trade name allegro topolyzer vario and is indicated for the wavelight allegretto wave® eye-q excimer laser system used in conjunction with the wavelight allegro topolyzer (topographer) or allegro topolyzer vario (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. 00 d of astigmatic component at the spectacle plane;2) in patients who are 18 years of age or older; and3) in patients with documentation of a stable manifest refraction defined as 0. 50 d or less of preoperative spherical equivalent shift over one year prior to surgery.

DeviceALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
Classification NameExcimer Laser System
Generic NameExcimer Laser System
ApplicantAlcon Laboratories, Inc.
Date Received2015-02-02
Decision Date2015-05-01
PMAP030008
SupplementS017
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
S035 2021-09-02 Real-time Process
S034 2021-04-12 Real-time Process
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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