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Multi-Purpose Disinfecting Solution ID 90746

by Alcon Laboratories, Inc. 2 variants

510(k) K984575

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK984575 Date14 Jan 1999ClearedStatusActive

Official records

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  • Withdrawn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, 19 Sep 2026

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

This device is a Multi-Purpose Disinfecting Solution for soft contact lenses, classified under Accessories, Soft Lens Products. It is designed to clean, rinse, disinfect, and store soft contact lenses, ensuring proper hygiene and maintenance for patient use.

The solution is supplied as a sterile, buffered, isotonic, aqueous chemical formulation containing preservatives (Polyquad and AL-6289) and surfactants (Tetronic 1304). Intended for single-use per lens case, it is regulated under FDA 510(k) clearance (K984575) as a Substantially Equivalent ophthalmic device (Special Classification, Class II). Compliance with Regulation 886.5928 ensures its suitability for home-based contact lens care.

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