BAUSCH& LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM

Excimer Laser System

FDA Premarket Approval P990027 S009

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 expansion of the physician adjustment range for the spherical component rom +2. 5 d to -1. 0 d.

DeviceBAUSCH& LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM
Classification NameExcimer Laser System
Generic NameExcimer Laser System
ApplicantTECHNOLAS PERFECT VISION GMBH
Date Received2006-12-19
Decision Date2008-02-01
PMAP990027
SupplementS009
Product CodeLZS
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address TECHNOLAS PERFECT VISION GMBH messerschmittstr 1 + 3 munchen 80992

Supplemental Filings

Supplement NumberDateSupplement Type
P990027Original Filing
S020 2015-10-07 30-day Notice
S019 2014-01-31 30-day Notice
S018 2012-05-01 Normal 180 Day Track
S017 2012-04-26 Real-time Process
S016 2010-09-17 135 Review Track For 30-day Notice
S015 2010-06-29 Normal 180 Day Track
S014
S013 2009-10-01 Real-time Process
S012 2009-05-15 Normal 180 Day Track No User Fee
S011 2008-09-03 Normal 180 Day Track
S010 2008-08-11 Normal 180 Day Track
S009 2006-12-19 Normal 180 Day Track
S008
S007 2004-09-10 Normal 180 Day Track
S006 2002-07-18 Panel Track
S005 2002-01-31 Normal 180 Day Track
S004 2001-12-14 Panel Track
S003 2001-04-27 Normal 180 Day Track
S002 2000-11-24 Panel Track
S001 2000-10-13 Normal 180 Day Track

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