PMA P040029S022

Device
Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact
Applicant
Euclid Vision Corporation
PMA number
P040029
Supplement
S022
Product code
NUU
Decision date
2024-04-15
Classification
Ophthalmic
Generic name
Lens, contact, orthokeratology, overnight
Approval order statement
an addition to the current blocking compounds used in manufacturing process originally approved in P040029

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
S022
Product code
NUU
Generic name
Lens, contact, orthokeratology, overnight
Decision date
2024-04-15
Decision code
OK30
Date received
2024-03-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
an addition to the current blocking compounds used in manufacturing process originally approved in P040029