PMA P040029S025

Device
Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact
Applicant
Euclid Vision Corporation
PMA number
P040029
Supplement
S025
Product code
NUU
Decision date
2026-03-12
Classification
Ophthalmic
Generic name
Lens, contact, orthokeratology, overnight
Approval order statement
updated branding, instructions for use, and alternate product labels for the Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear

Current openFDA PMA Record#

Device
Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact
Applicant
Euclid Vision Corporation
PMA number
P040029
Supplement
S025
Product code
NUU
Generic name
Lens, contact, orthokeratology, overnight
Decision date
2026-03-12
Decision code
APPR
Date received
2025-12-15
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
updated branding, instructions for use, and alternate product labels for the Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear