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Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens

by Visco Vision, Inc.

510(k) K181349

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 · Traditional NumberK181349 Date19 Sep 2018ClearedStatusActive

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  • Withdrawn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
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 886.5925
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens is a daily wear, single-use soft contact lens made of olifilcon B material. It is indicated for the correction of refractive ametropia, including myopia and hyperopia, in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

This device is supplied as a single-use contact lens and is regulated under FDA 510(k) with K181349, classified under product code LPL as Lenses, Soft Contact, Daily Wear. The device is manufactured by Visco Vision, Inc. and received FDA clearance on September 19, 2018, as substantially equivalent under regulation 886.5925.

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Questions

AI-generated answers, 6 Oct 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 Vexillum contact lens used for?

    The Vexillum contact lens is designed for the correction of refractive ametropia, including myopia and hyperopia, in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

  • Is the Vexillum contact lens reusable or single-use?

    The Vexillum contact lens is supplied as a single-use contact lens and is intended for daily wear only. It should not be reused or worn for extended periods beyond the recommended daily use.

  • What is the material composition of the Vexillum contact lens?

    The Vexillum contact lens is made of olifilcon B material, which is a silicone hydrogel compound designed for comfort and oxygen permeability in daily wear contact lenses.

  • What is the regulatory status of the Vexillum contact lens?

    The Vexillum contact lens is regulated under FDA 510(k) with K181349, classified under product code LPL as Lenses, Soft Contact, Daily Wear. It received FDA clearance on September 19, 2018, as substantially equivalent under regulation 886.5925.