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Karats Multipurpose Solution

by Ciba Vision Corporation 2 variants

510(k) K021635

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 NumberK021635 Date28 Oct 2002ClearedStatusActive

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  • Withdrawn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
LPN
Device Class
Class II
Regulation
21 CFR Part 886.5928
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.

Karats Multipurpose Solution is a soft contact lens care solution designed for cleaning, rinsing, disinfecting, and storing hydrophilic contact lenses. It is intended to help increase contact lens comfort and provide a better lens wear experience.

The solution is supplied as a multipurpose product for contact lens care and is regulated under product code LPN. It received FDA 510(k) clearance on October 28, 2002, with the authorization number K021635. The solution is manufactured by Ciba Vision Corporation and is classified under the Ophthalmic advisory committee.

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