VISX EXCIMER LASER SYSTEM MODELS B AND C

Excimer Laser System

FDA Premarket Approval P930016

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the visx excimer laser system (models b and c)

• Device: VISX EXCIMER LASER SYSTEM MODELS B AND C
• Classification Name: Excimer Laser System
• Generic Name: Excimer Laser System
• Applicant: AMO Manufacturing USA, LLC
• Date Received: 1993-06-15
• Decision Date: 1996-03-27
• Notice Date: 1997-03-25
• PMA: P930016
• Supplement: S
• Product Code: LZS
• Docket Number: 97M-0084
• Advisory Committee: Ophthalmic
• Expedited Review: No
• Combination Product: No
• Applicant Address: AMO Manufacturing USA, LLC 510 Cottonwood Drive milpitas, CA 95035
• Post-Approval Study: Show Report Schedule and Study Progress

Supplemental Filings

Supplement Number	Date	Supplement Type
P930016		Original Filing
S062	2020-10-01	Normal 180 Day Track No User Fee
S061	2019-11-25	Real-time Process
S060	2019-10-31	Real-time Process
S059	2019-03-29	Normal 180 Day Track No User Fee
S058	2019-01-22	Real-time Process
S057
S056	2018-12-31	Real-time Process
S055	2018-07-16	Normal 180 Day Track No User Fee
S054	2017-12-01	Real-time Process
S053	2017-09-29	Normal 180 Day Track
S052	2017-06-12	30-day Notice
S051	2017-05-16	Real-time Process
S050	2017-03-16	30-day Notice
S049	2016-12-27	30-day Notice
S048	2016-12-01	Panel Track
S047	2015-11-17	Real-time Process
S046	2015-10-19	Real-time Process
S045	2015-06-01	Panel Track
S044	2014-11-10	Panel Track
S043	2014-07-07	Real-time Process
S042	2014-05-19	30-day Notice
S041
S040	2014-05-01	30-day Notice
S039
S038	2013-05-28	Special (immediate Track)
S037
S036	2011-10-28	30-day Notice
S035	2011-08-29	Normal 180 Day Track
S034	2010-09-20	Normal 180 Day Track
S033
S032	2009-09-18	Normal 180 Day Track
S031	2008-08-11	Normal 180 Day Track
S030	2007-11-21	Real-time Process
S029
S028	2007-10-29	Normal 180 Day Track No User Fee
S027	2007-08-08	Normal 180 Day Track
S026	2006-10-24	Real-time Process
S025	2006-09-29	Panel Track
S024	2006-03-30	Real-time Process
S023	2005-08-12	Real-time Process
S022	2005-03-30	Real-time Process
S021	2005-03-08	Panel Track
S020	2004-09-21	Panel Track
S019	2004-09-07	Normal 180 Day Track
S018
S017	2003-11-28	Panel Track
S016	2002-10-01	Panel Track
S015	2002-07-30	Real-time Process
S014	2001-06-04	Panel Track
S013	2001-02-05	Normal 180 Day Track
S012	2000-07-14	Panel Track
S011	2000-04-12	Real-time Process
S010	1999-06-18	Panel Track
S009
S008
S007	1998-03-05	Panel Track
S006	1998-02-26	Real-time Process
S005	1997-07-23	Panel Track
S004	1996-12-17	Normal 180 Day Track
S003	1996-08-26	Panel Track
S002	1996-05-16	Normal 180 Day Track
S001	1996-04-18	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
05050474651456	P930016	053
05050474651449	P930016	053
05050474651432	P930016	053
05050474620278	P930016	053