Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil

FDA Premarket Approval P040029 S012

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

Changes in the software that generates the code for lathing euclid systems orthokeratology contact lenses for overnight wear

DeviceEuclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil
Generic NameLens, Contact, Orthokeratology, Overnight
ApplicantEuclid Systems Corporation
Date Received2020-01-31
Decision Date2020-02-28
PMAP040029
SupplementS012
Product CodeNUU 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Euclid Systems Corporation 2776 Towerview Rd. herndon, VA 20171

Supplemental Filings

Supplement NumberDateSupplement Type
P040029Original Filing
S012 2020-01-31 30-day Notice
S011
S010
S009 2019-06-26 Normal 180 Day Track
S008 2019-05-08 Real-time Process
S007 2019-03-15 30-day Notice
S006
S005 2017-08-09 30-day Notice
S004 2016-12-27 Normal 180 Day Track
S003 2016-01-29 Normal 180 Day Track No User Fee
S002 2015-08-03 Normal 180 Day Track No User Fee
S001 2005-08-29 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
85000713500232 P040029 000
85000713599960 P040029 000
85000713599991 P040029 000
85000713599984 P040029 000
85000713500102 P040029 000
85000713500119 P040029 000
85000713500126 P040029 000
85000713500133 P040029 000
85000713500140 P040029 000
85000713500157 P040029 000
85000713500164 P040029 000
85000713500171 P040029 000
85000713500188 P040029 000
85000713500195 P040029 000
85000713500218 P040029 000
85000713500225 P040029 000
85000713599977 P040029 000

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