iDESIGN Refractive Studio

FDA Premarket Approval P930016 S060

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 four (4) minor software changes to the idesjgn refractive studio.

DeviceiDESIGN Refractive Studio
Generic NameExcimer Laser System
ApplicantAMO Manufacturing USA, LLC
Date Received2019-10-31
Decision Date2020-01-28
PMAP930016
SupplementS060
Product CodeLZS 
Advisory CommitteeOphthalmic
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address AMO Manufacturing USA, LLC 510 Cottonwood Drive milpitas, CA 95035

Supplemental Filings

Supplement NumberDateSupplement Type
P930016Original Filing
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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