PMA P040029S023

Device: Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact
Applicant: Euclid Vision Corporation
PMA number: P040029
Supplement: S023
Product code: NUU
Decision date: 2025-05-23
Classification: Ophthalmic
Generic name: Lens, contact, orthokeratology, overnight
Approval order statement: approval for additional models (brandings) and updated instructions for use for Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear lenses.

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: S023
Product code: NUU
Generic name: Lens, contact, orthokeratology, overnight
Decision date: 2025-05-23
Decision code: APPR
Date received: 2024-06-28
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for additional models (brandings) and updated instructions for use for Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear lenses.