Euclid Systems Orthokeratology (oprifocon A) or (tisilfocon A) Contact Lenses for Overnight Wear

FDA Premarket Approval P040029 S014

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 model name additions to the euclid systems orthokeratology (oprifocon a) or (tisilfocon a) contact lenses for overnight wear lenses.

DeviceEuclid Systems Orthokeratology (oprifocon A) or (tisilfocon A) Contact Lenses for Overnight Wear
Generic NameLens, Contact, Orthokeratology, Overnight
ApplicantEuclid Systems Corporation
Date Received2020-02-26
Decision Date2020-08-24
Product CodeNUU 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Euclid Systems Corporation 2776 Towerview Rd. herndon, VA 20171

Supplemental Filings

Supplement NumberDateSupplement Type
P040029Original Filing
S014 2020-02-26 Normal 180 Day Track No User Fee
S012 2020-01-31 30-day Notice
S009 2019-06-26 Normal 180 Day Track
S008 2019-05-08 Real-time Process
S007 2019-03-15 30-day Notice
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


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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