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FreshLook One-Day Color Contact Lens

by Ciba Vision Corporation

510(k) K050213

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 NumberK050213 Date28 Mar 2005ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 1 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 FreshLook One-Day Color Contact Lens is a disposable soft contact lens designed to enhance or alter natural eye color. Classified as a cosmetic contact lens, it provides a range of youthful and vibrant hues while maintaining optical clarity for daily wear. These lenses are intended for individuals seeking temporary color changes without the need for permanent modifications.

Supplied as a single-use product, each lens is intended for one-day wear and disposal, ensuring hygiene and convenience. The lenses are non-prescription and do not correct vision but are available in various color options. They are regulated under FDA 510(k) clearance (K050213) and fall under the Ophthalmic specialty category. No sterilization or reusability is specified, and MRI safety is not addressed in the provided data.

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Questions

AI-generated answers, 1 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 FreshLook One-Day Color Contact Lens used for?

    The FreshLook One-Day Color Contact Lens is designed to enhance or alter natural eye color temporarily. It is classified as a cosmetic contact lens and is intended for individuals who want to change their eye color for aesthetic purposes without permanent modifications. These lenses do not correct vision and are meant for daily wear only.

  • How is the FreshLook One-Day Color Contact Lens supplied?

    Each lens is supplied as a single-use product, meaning one lens is intended for one day of wear and should be discarded afterward. This ensures hygiene and convenience for users. The lenses come in various color options to suit different preferences.

  • Are the FreshLook One-Day Color Contact Lenses reusable or sterile?

    The FreshLook One-Day Color Contact Lenses are intended for single-use only and are not designed for reuse. Since they are disposable, there is no need for sterilization procedures. Always follow the manufacturer’s instructions for proper use and disposal.

  • What sizes or models are available for the FreshLook One-Day Color Contact Lens?

    The FreshLook One-Day Color Contact Lens is available in multiple registration numbers, indicating various models or color options. These models are categorized under the product code MVN and are intended for different aesthetic preferences. For specific sizing, refer to the manufacturer’s detailed product guide or consult an eye care professional.

  • How should the FreshLook One-Day Color Contact Lenses be stored?

    Since these lenses are single-use and disposable, they should be stored in a clean, dry environment as per the manufacturer’s guidelines. If stored in a multi-pack or blister pack, ensure the packaging remains intact until use. Always check the expiration date and follow the instructions provided to maintain lens integrity.