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Aosept Clear Care Cleaning and Disinfecting Solution

by Ciba Vision Corporation 5 variants

510(k) K013512

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 NumberK013512 Date20 Dec 2001ClearedStatusActive

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  • Withdrawn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, 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.

The Aosept Clear Care Cleaning and Disinfecting Solution is a Class II ophthalmic device designed for cleaning and disinfecting soft contact lenses. It is classified under the product code LPN and is intended for use as an accessory to soft lens products.

This solution is supplied as a single-use product and is not indicated for MRI use. It is authorized under FDA 510K clearance with K number K013512 and is manufactured by Ciba Vision Corporation. The device is stored at room temperature and should be used according to the manufacturer's instructions.

Other devices from Ciba Vision Corporation

See all devices from Ciba Vision Corporation →

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 is the AOSEPT Clear Care Cleaning and Disinfecting Solution used for?

    The AOSEPT Clear Care Cleaning and Disinfecting Solution is a Class II ophthalmic device designed specifically for cleaning and disinfecting soft contact lenses. It is intended to be used as an accessory to soft lens products.

  • Is the AOSEPT Clear Care Solution single-use or reusable?

    The AOSEPT Clear Care Cleaning and Disinfecting Solution is supplied as a single-use product. It is not intended for multiple uses and should be used according to the manufacturer's instructions.

  • How should the AOSEPT Clear Care Solution be stored?

    The AOSEPT Clear Care Cleaning and Disinfecting Solution should be stored at room temperature. Proper storage conditions help maintain the solution's effectiveness for its intended use.

  • What is the regulatory status of the AOSEPT Clear Care Solution?

    The AOSEPT Clear Care Cleaning and Disinfecting Solution is authorized under FDA 510K clearance with K number K013512. It is classified as a Class II ophthalmic device and is manufactured by Ciba Vision Corporation.