Methafilcon A Soft Hydrophilic Sperical/Toric Contact Lenses

FDA PMAFDA 510(k)

Class III (US FDA PMA)

PMA P850079510(k) K002625

by Coopervision Inc.

Identity

Trade Name: HYDRASOFT (METHAFILCON B) CONTACT LENS FDA PMA
Generic Name: Lenses, soft contact, extended wear FDA PMA

Identifiers

PMA Number: P850079 FDA PMA
510(k) Number: K002625 FDA PMA
FDA Product Code: LPL FDA PMA

Classification

Device Class: Class II FDA PMA
Legislation / Framework: 21 CFR Part 886.5925 FDA PMA
Regulation Number: 886.5925 FDA PMA
Advisory Committee: Ophthalmic FDA PMA
FDA Decision: SESE Substantially Equivalent FDA PMA

Methafilcon A soft hydrophilic contact lenses are ophthalmic devices designed for the correction of vision. These lenses are available in both spherical and toric configurations to accommodate various refractive needs.

These contact lenses are intended for daily wear and are manufactured by CooperVision, Inc. The device is classified as a Class 2 medical device under the ophthalmic specialty and is regulated under the product code LPL.

Frequently asked questions

What type of contact lenses are these?

These are soft hydrophilic contact lenses, which are designed for daily wear to assist with vision correction.

Who is the manufacturer of these lenses?

These lenses are manufactured by CooperVision, Inc., based in Scottsville, New York.

Are these lenses available in different designs?

Yes, the Methafilcon A lenses are available in both spherical and toric designs to address different types of refractive errors.

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: 510 (k) Summary - accessdata.fda.gov, CooperVision Hydrasoft Methafilcon B Soft Hydrophilic Contact ..., List of soft contact lens materials - Wikipedia, Food and Drug Administration Center for Devices and Radiological ..., Contact lenses: clinical evaluation, associated challenges and ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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	K002625	Class III	Active
FDA 510(k)	United States	FDA_510K	K001090	Class III	Active
FDA PMA	United States	FDA_PMA	P850079	Class III	Active

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Manufacturer

Manufacturer: Coopervision Inc.
FDA Applicant: CooperVision, Inc.

Sources (2)

FDA PMA P850079 37 fields · synced Sep 18, 2026
FDA 510(k) K002625 1 fields · synced May 18, 2026