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C-Vue 55 Toric (Methafilcon a) Multifocal Contact Lens

by Unilens Corp., USA

510(k) K041608

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK041608 Date7 Jul 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LPL
Device Class
Class II
Regulation
21 CFR Part 886.5925
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a soft contact lens made of methafilcon A material, designed as a toric multifocal lens for daily wear. It is intended for the correction of refractive ametropia, including myopia and hyperopia, presbyopia, and astigmatism up to 4.00 diopters in aphakic and/or non-aphakic persons with non-diseased eyes.

The lens is supplied as a reusable device for quarterly replacement and is indicated for daily wear. It is regulated under FDA 510(k) clearance (K041608) and classified as a Class II medical device under regulation number 886.5925, with product code LPL. The device is manufactured by Unilens Corp., USA, and is authorized for marketing in the United States.

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Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the C-VUE 55 Toric multifocal contact lens used for?

    It is intended for the correction of refractive ametropia, including myopia and hyperopia, presbyopia, and astigmatism up to 4.00 diopters in aphakic and/or non-aphakic persons with non-diseased eyes.

  • How is the C-VUE 55 Toric multifocal contact lens supplied and replaced?

    The lens is supplied as a reusable device for quarterly replacement and is indicated for daily wear, meaning it is worn during waking hours and removed each night.

  • What material is the C-VUE 55 Toric multifocal contact lens made of?

    The lens is made of methafilcon A, a soft contact lens material known for its water content and oxygen permeability, suitable for daily wear.