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Opti-Free Rinsing, Disinfecting & Storage Solution

by Alcon Laboratories, Inc.

PMA P830034

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA P830034↗

FDA record

Trust

Unverified

Source FDA PMA, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberP830034 Date22 Oct 1985ApprovedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Trade name
Polyquat Disinfection System
Generic name
Accessories, soft lens products
FDA applicant
Alcon Laboratories
PMA number
FDA product code
LPN
Device class
Class II
Regulation
21 CFR Part 886.5928
Advisory committee
Ophthalmic
FDA decision
APPR Approved
PMA supplement
S001

Overview

AI-generated summary, 18 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 soft lens product accessory designed for rinsing, disinfecting, and storing soft contact lenses. It falls under the classification of ophthalmic accessories and is intended to maintain lens hygiene through chemical disinfection and storage in a sterile solution.

The solution is supplied as a multi-use liquid for rinsing, disinfecting, and overnight storage of soft contact lenses. It is classified as a Class II device under FDA regulations and requires a PMA (Premarket Approval). The product is intended for use in ophthalmic settings and is not MRI-compatible. Storage conditions and single-use or reusable status are not specified in the provided data.

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