PMA P040029S016

Device
Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil
Applicant
Euclid Vision Corporation
PMA number
P040029
Supplement
S016
Product code
NUU
Decision date
2021-02-04
Generic name
Lens, contact, orthokeratology, overnight
Approval order statement
Approval for model name additions to the Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear

Current openFDA PMA Record#

Device
Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil
Applicant
Euclid Vision Corporation
PMA number
P040029
Supplement
S016
Product code
NUU
Generic name
Lens, contact, orthokeratology, overnight
Decision date
2021-02-04
Decision code
APPR
Date received
2020-08-12
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 (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear