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Gentle Touch UV (Netrafilcon A) Soft Contact Lenses

by Wesley Jessen Corp.

510(k) K991000

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 NumberK991000 Date28 Jun 1999ClearedStatusActive

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  • Withdrawn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, 23 Sep 2026

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

Gentle Touch UV (Netrafilcon A) Soft Contact Lenses are ophthalmic devices made of netrafilcon A material designed for daily wear. These lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The lenses are to be disinfected using a recommended chemical disinfection system or hydrogen peroxide disinfection system. They are classified as Class II devices under product code LPL for Lenses, Soft Contact, Daily Wear, with FDA 510(k) clearance K991000 obtained in 1999.

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Questions

AI-generated answers, 23 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 are Gentle Touch UV Soft Contact Lenses made of?

    Gentle Touch UV Soft Contact Lenses are made of netrafilcon A material, designed for daily wear to help protect against transmission of harmful UV radiation to the cornea and into the eye.

  • How should these contact lenses be disinfected?

    These lenses should be disinfected using a recommended chemical disinfection system or hydrogen peroxide disinfection system to maintain proper hygiene and lens condition.

  • What is the regulatory classification of these contact lenses?

    Gentle Touch UV Soft Contact Lenses are classified as Class II devices under product code LPL for Lenses, Soft Contact, Daily Wear, with FDA 510(k) clearance K991000 obtained in 1999.

  • Are these lenses reusable or single-use?

    These lenses are designed for daily wear, meaning they should be removed and disinfected each night, but can be reused for multiple days following proper care and disinfection protocols.