PMA P040029S017

Device
Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear
Applicant
Euclid Vision Corporation
Product code
NUU
Decision date
2021-03-30
Generic name
Lens, contact, orthokeratology, overnight
Approval order statement
Approval for model name additions to the Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear

Current openFDA PMA Record#

Device
Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear
Applicant
Euclid Vision Corporation
PMA number
P040029
Supplement
S017
Product code
NUU
Generic name
Lens, contact, orthokeratology, overnight
Decision date
2021-03-30
Decision code
APPR
Date received
2020-10-09
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for model name additions to the Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear