PMA P240045

Device
Optimum Infinite (tisilfocon A) Orthokeratology Lenses II
Applicant
Contamac, Ltd.
PMA number
P240045
Product code
NUU
Decision date
2026-02-10
Classification
Ophthalmic
Generic name
Lens, contact, orthokeratology, overnight
Approval order statement
Approval for Optimum Infinite (tisilfocon A) Ortho-k Lenses, Optimum Infinite (tisilfocon A) Orthokeratology Lenses II.

Current openFDA PMA Record#

Device
Optimum Infinite (tisilfocon A) Orthokeratology Lenses II
Applicant
Contamac, Ltd.
PMA number
P240045
Product code
NUU
Generic name
Lens, contact, orthokeratology, overnight
Decision date
2026-02-10
Decision code
APPR
Date received
2024-12-17
Approval order statement
Approval for Optimum Infinite (tisilfocon A) Ortho-k Lenses, Optimum Infinite (tisilfocon A) Orthokeratology Lenses II.