FDA.reportPublic FDA data

PMA P040029S015

Device
Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear
Applicant
Euclid Vision Corporation
PMA number
P040029
Supplement
S015
Product code
NUU
Decision date
2020-12-17
Generic name
Lens, contact, orthokeratology, overnight
Approval order statement
Approval for the addition of an alternate lens blank material color (green) for the manufacture of the Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear.

Current openFDA PMA Record#

Device
Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear
Applicant
Euclid Vision Corporation
PMA number
P040029
Supplement
S015
Product code
NUU
Generic name
Lens, contact, orthokeratology, overnight
Decision date
2020-12-17
Decision code
APPR
Date received
2020-05-29
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the addition of an alternate lens blank material color (green) for the manufacture of the Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear.