VISX EXCIMER LASER SYSTEM MODELS B AND C

Excimer Laser System

FDA Premarket Approval P930016 S005

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 the visx excimer laser system (models b and c). This device is indicated for myopic and astigmatic prk using an ablation zone with a 6. 0 mm major axis. The prk procedure is intended for use: 1)in patients with documented evidence of a change in manifest refraction of less than or equal to 0. 5d (in both cylinder and sphere components) per year for at least one year prior to the date of the pre-operative examination; and 2) in patients 18-20 years of age in prk treatments for the reduction or elimination of myopia (nearsightedness) of less than or equal to -6. 0 d spherical equivelent at the corneal plane with less than or equal to -1. 0 d of astigmatism; or 3) in patients 21 years of age or older in prk treatments for the reduction or elimination of myopia (nearsightedness) of between 0 and -12. 0 d spherical myopia at the spectacle plane and up to -4. 0 d of astigmatism.

DeviceVISX EXCIMER LASER SYSTEM MODELS B AND C
Classification NameExcimer Laser System
Generic NameExcimer Laser System
ApplicantAMO Manufacturing USA, LLC
Date Received1997-07-23
Decision Date1998-01-29
Notice Date1999-07-15
PMAP930016
SupplementS005
Product CodeLZS
Docket Number99M-0293
Advisory CommitteeOphthalmic
Supplement TypePanel Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewYes
Combination Product No
Applicant Address AMO Manufacturing USA, LLC 510 Cottonwood Drive milpitas, CA 95035
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P930016Original 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 IDPMASupp
05050474651456 P930016 053
05050474651449 P930016 053
05050474651432 P930016 053
05050474620278 P930016 053

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