Question 1

What types of medical devices does Menicon Co., Ltd. manufacture?

Accepted Answer

Menicon Co., Ltd. specializes in corrective contact lenses, producing both soft and rigid-gas-permeable (RGP) varieties. Their soft lenses are primarily designed for daily-disposable use, while their RGP lenses cater to daily-wear and extended-wear applications. Examples include single-use soft lenses like the Miru 1day series and reusable RGP lenses such as the 1-Day Flat Pack CP90 BC840. These products are packaged in formats like flat packs for trial or refill purposes.

Question 2

Where is Menicon Co., Ltd. based, and how does this affect its regulatory compliance?

Accepted Answer

Menicon Co., Ltd. is based in the United States, which means its devices are subject to U.S. regulatory requirements, including those set by the FDA. Since contact lenses are classified as medical devices, the company must comply with FDA guidelines for manufacturing, labeling, and post-market surveillance. The U.S. location also influences where its devices are listed in regulatory databases, such as the FDA’s Unique Device Identifier (UDI) system.

Question 3

In which regulatory registries are Menicon Co., Ltd.’s devices listed, and why?

Accepted Answer

Menicon Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is mandatory for Class II and Class III devices in the U.S., ensuring traceability and transparency in the supply chain. The UDI system helps healthcare providers, regulators, and other stakeholders verify device details, including manufacturer information, device descriptions, and regulatory status. Since contact lenses fall under these classifications, they must be included in the UDI database to comply with FDA requirements.

Question 4

How are Menicon Co., Ltd.’s contact lenses classified under FDA regulations?

Accepted Answer

Menicon Co., Ltd.’s contact lenses are classified as either Class II or Class III devices under FDA regulations. Class II devices generally require special controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance. Class III devices, which typically involve higher risks, require pre-market approval (PMA) due to insufficient data from lesser-stringent classifications. The classification depends on factors like the device’s intended use, potential risks, and benefits, as outlined in the FDA’s regulatory framework for contact lenses.

Device	Model / Reference	Registries	Class	Status
1-Day Flat Pack Trial9 BC840	-9.75	FDA UDI	Class II	Active
Miru 1day Menicon Flat Pack TC CP30	-2.00/-0.75/15	FDA UDI	Class II	Active
1-Day Flat Pack TC CP90	-12.50/-1.25/165	FDA UDI	Class II	Active
Miru 1day Menicon Flat Pack CP30	+3.75	FDA UDI	Class II	Active
Miru 1day Menicon Flat Pack TC Trial6	-9.00/-0.75/15	FDA UDI	Class II	Active
Miru 1day Menicon Flat Pack TC CP90	-9.00/-0.75/15	FDA UDI	Class II	Active
Miru 1day Menicon Flat Pack CP30	-11.50	FDA UDI	Class II	Active
Miru 1day Menicon Flat Pack TC CP90	+4.50/-1.75/180	FDA UDI	Class II	Active
Miru 1day Menicon Flat Pack TC CP30	-1.75/-1.25/180	FDA UDI	Class II	Active
One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens	K180819	FDA 510(k)	Class II	Active
Menicon Unique Ph Multi-Purpose Solution	K130805	FDA 510(k)	Class II	Active
Melafocon A/Rigid Gas Perm Contact Len For Daily Wear	K943784	FDA 510(k)	Class II	Active
Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lens	K103561	FDA 510(k)	Class II	Active
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses	K173136	FDA 510(k)	Class II	Active
Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lens	K962006	FDA 510(k)	Class II	Active
Menicon Saline Rinse Solution	K151768	FDA 510(k)	Class II	Active
Miru 1day UpSide (midafilcon A)	K193399	FDA 510(k)	Class II	Active
Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution	K191872	FDA 510(k)	Class II	Active
Menicon Progent Remover	K002140	FDA 510(k)	Class II	Active
Menicon Progent Protein Remover For Rigid Gas Permeable Contact Lens	K122273	FDA 510(k)	Class II	Active
Menicon Progent Protein Remover For Rigid Gas Permeable Contact Lenses	K082855	FDA 510(k)	Class II	Active
Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens	K180004	FDA 510(k)	Class II	Active
One Day Flat Pack	K102895	FDA 510(k)	Class II	Active
Menicon Progent Remover For Rigid Gas Permeable Contact Lenses	K020930	FDA 510(k)	Class II	Active
Menicon Z Rigid Gas Permeable Contact Lens	K081443	FDA PMA	Class III	Active
Menicon Sf-P (melafocon A) Contact Lens	K000233	FDA PMA	Class III	Active

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