Menicon SF-P Melafocon A Contact Lens

FDA PMAFDA 510(k)

Class III (US FDA PMA)

PMA P880098510(k) K000233

by Menicon Co., Ltd.

Identity

Trade Name: MENICON SF-P RGP (MELAFOCON A) CONTACT LENS FDA PMA
Generic Name: Lens, contact (rigid gas permeable), extended wear FDA PMA

Identifiers

PMA Number: P880098 FDA PMA
510(k) Number: K000233 FDA PMA
FDA Product Code: MWL FDA PMA

Classification

Device Class: Class III FDA PMA
Legislation / Framework: 21 CFR Part 886.5916 FDA PMA
Regulation Number: 886.5916 FDA PMA
Advisory Committee: Ophthalmic FDA PMA
FDA Decision: APWD FDA PMA

The Menicon SF-P is a rigid gas permeable contact lens designed for extended wear. It is composed of the material melafocon A and is classified as an ophthalmic device intended for vision correction.

This device is manufactured by Menicon Co., Ltd. and has received FDA 510(k) and PMA authorizations. It is categorized under regulation number 886.5916 and product code MWL for use in ophthalmic applications.

Frequently asked questions

What type of material is the Menicon SF-P made from?

The Menicon SF-P contact lens is manufactured using melafocon A, which is a rigid gas permeable material.

Is the Menicon SF-P intended for daily or extended wear?

The Menicon SF-P is classified as a rigid gas permeable contact lens specifically indicated for extended wear.

Has this device received regulatory authorization?

Yes, the Menicon SF-P has received both FDA 510(k) and PMA authorizations for its use as an ophthalmic device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Menicon Corporate Website

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K000233	Class III	Active
FDA PMA	United States	FDA_PMA	P880098	Class III	Active

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Manufacturer

Manufacturer: Menicon Co., Ltd.
FDA Applicant: Menicon Co, Ltd.

Sources (2)

FDA PMA P880098 37 fields · synced Sep 18, 2026
FDA 510(k) K000233 1 fields · synced May 18, 2026