NIDEK EC-5000 EXCIMER LASER SYSTEM

Excimer Laser System

FDA Premarket Approval P970053 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 nidek ec-5000 excimer laser system. The device uses a 6. 0 mm optical zone and a 9. 0 mm treatment zone and is indicated for laser assisted in-situ keratomileusis (lasik): 1) for the reduction or elimination of hyperopia refractive errors from +0. 5 to +5. 0 d of sphere with or without astigmatic refractive errors from +0. 5 to +2. 0 d at the spectacle plane with manifest refraction spherical equivalent (mrse) of +5. 0 d or less; 2) in patients 21 years of age or older; and 3) in patients with documented stability of manifest refraction over the prior year, demonstrated by a change in mrse not greater than +/- 0. 50 diopter.

DeviceNIDEK EC-5000 EXCIMER LASER SYSTEM
Classification NameExcimer Laser System
Generic NameExcimer Laser System
ApplicantNIDEK CO., LTD.
Date Received2005-11-23
Decision Date2006-10-11
Notice Date2006-11-14
PMAP970053
SupplementS009
Product CodeLZS
Docket Number06M-0460
Advisory CommitteeOphthalmic
Supplement TypePanel Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address NIDEK CO., LTD. 34-14 Maehama, Hiroishi-cho gamagori, Aichi 443-0-0038
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P970053Original Filing
S017 2017-07-17 Normal 180 Day Track
S016 2017-03-13 Real-time Process
S015 2014-10-03 Normal 180 Day Track
S014 2014-08-18 Real-time Process
S013 2014-02-11 Normal 180 Day Track
S012 2012-09-25 Normal 180 Day Track
S011 2007-03-30 Panel Track
S010 2006-08-08 Normal 180 Day Track
S009 2005-11-23 Panel Track
S008 2004-04-19 Real-time Process
S007 2002-05-23 Normal 180 Day Track
S006 2001-03-15 Normal 180 Day Track
S005 2001-01-30 Normal 180 Day Track
S004
S003 2000-04-28 Normal 180 Day Track
S002 1999-04-19 Panel Track
S001 1999-02-16 Panel Track

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