Menicon Co, Ltd.

Code	Device name	Class	Specialty	Clearances	Most recent
LPN	Accessories, Soft Lens Products	Class II	Ophthalmic	2	2026-08-13
LPL	Lenses, Soft Contact, Daily Wear	Class II	Ophthalmic	1	2020-06-17

Date	PMA #	Trade name	Type	Code	Device name	Specialty
2023-06-16	P990018-S010	ACUVUE® AbilitiTM Overnight; ACUVUE® AbilitiTM Overnight Therapeutic Lenses For Myopia Management; Menicon Z Night (Ti	30-Day Notice	MWL	Lens, Contact (Rigid Gas Permeable), Extended Wear	Ophthalmic
2023-05-01	P990018-S009	Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear, ACUVUE® Abiliti Overnight and ACUVUE® Abiliti Overni	Real-Time Process	NUU	Lens, Contact, Orthokeratology, Overnight	Ophthalmic
2022-11-16	P990018-S007	Menicon Z (tisilfocon) Rigid Gas Permeable Contact Lens and Menicon Z Night (tisilfocon A) Contact Lenses for Overnight	Normal 180 Day Track	MWL	Lens, Contact (Rigid Gas Permeable), Extended Wear	Ophthalmic
2022-08-02	P990018-S008	Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear; ACUVUE® Abiliti Overnight and ACUVUE® Abiliti Overni	Normal 180 Day Track	NUU	Lens, Contact, Orthokeratology, Overnight	Ophthalmic
2021-05-06	P990018-S006	ACUVUE® Abiliti Overnight and ACUVUE® Abiliti Overnight Therapeutic Lenses for Myopia Management	Normal 180 Day Track No User Fee	NUU	Lens, Contact, Orthokeratology, Overnight	Ophthalmic

Date	K-number	Device	Code	Class	Specialty
2026-08-13	K253795	MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution	LPN	Class II	Ophthalmic
2020-06-17	K193399	Miru 1day UpSide (midafilcon A)	LPL	Class II	Ophthalmic
2020-03-02	K191872	Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution	LPN	Class II	Ophthalmic

Clearance cadence by quarter