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Opti-One Multi-Purpose Solution

by Alcon Laboratories, Inc.

510(k) K983973

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 NumberK983973 Date18 Dec 1998ClearedStatusActive

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  • Withdrawn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
FDA applicant
Alcon Laboratories
Device class
Class II
Regulation
21 CFR Part 886.5928
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 Opti-One Multi-Purpose Solution is a Class II ophthalmic device designed for cleaning, disinfecting, and rinsing contact lenses immediately before insertion into the eyes. This solution serves as an accessory for soft lens products, providing essential lens maintenance to ensure safe and comfortable contact lens wear.

The device is supplied as a multi-purpose solution and is intended for single-use contact lens care. It is regulated under FDA 510(k) clearance with product code LPN and was determined to be substantially equivalent on December 18, 1998. The solution is manufactured by Alcon Laboratories, Inc. and is not indicated for MRI safety or specific storage conditions beyond standard requirements.

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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 Opti-One Multi-Purpose Solution used for?

    The Opti-One Multi-Purpose Solution is designed for cleaning, disinfecting, and rinsing soft contact lenses immediately before insertion into the eyes. It serves as an essential accessory for soft lens products to ensure safe and comfortable contact lens wear.

  • Is the Opti-One Multi-Purpose Solution single-use or reusable?

    The Opti-One Multi-Purpose Solution is intended for single-use contact lens care. It is designed to be used as needed for lens maintenance and should not be reused beyond its intended purpose for optimal safety and effectiveness.

  • What regulatory status does the Opti-One Multi-Purpose Solution have?

    The Opti-One Multi-Purpose Solution is regulated under FDA 510(k) clearance with product code LPN. It was determined to be substantially equivalent on December 18, 1998, and is classified as a Class II ophthalmic device.

  • How is the Opti-One Multi-Purpose Solution supplied?

    The Opti-One Multi-Purpose Solution is supplied as a multi-purpose solution in its original packaging. It is manufactured by Alcon Laboratories, Inc. and is designed specifically for contact lens care as an accessory for soft lens products.