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Flexsol

by Alcon Laboratories, Inc.

PMA N17974

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 N17974

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberN17974 Date19 Jun 1980ApprovedStatusActive

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  • Withdrawn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 PMA Active

Specification

PMA

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
S021

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.

The FlexSol Daily Cleaning Solution is a soft lens cleaning product designed for maintaining contact lenses. Classified under the nomenclature for accessories and soft lens products, it is intended for routine cleaning and care of soft contact lenses to ensure hygiene and comfort for wearers with sensitive eyes.

This solution is supplied as a sterile, single-use product for home use. It is regulated under FDA Premarket Approval (PMA) with approval number N17974 and falls under device classification II. The product is intended for use in ophthalmic settings, adhering to regulatory standards for soft lens care solutions. Storage and handling instructions are not specified in the data but must follow manufacturer guidelines to maintain sterility and efficacy.

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Questions

AI-generated answers, 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.

  • What is the FlexSol Daily Cleaning Solution intended for and who should use it?

    The FlexSol Daily Cleaning Solution is designed specifically for maintaining soft contact lenses through routine cleaning and care. It is formulated for wearers with sensitive eyes, helping to ensure hygiene and comfort during use. This product is not intended for hard contact lenses or other ocular applications.

  • Is the FlexSol Daily Cleaning Solution sterile and how is it supplied?

    Yes, the FlexSol Daily Cleaning Solution is supplied as a sterile product. It is intended for single-use at home, meaning each unit is meant to be used once before disposal. This design helps maintain sterility and reduce the risk of contamination.

  • What regulatory pathway does the FlexSol Daily Cleaning Solution follow?

    The FlexSol Daily Cleaning Solution follows the FDA Premarket Approval (PMA) pathway, with approval number N17974. This classification (Device Class II) indicates it has undergone rigorous review to ensure safety and effectiveness for its intended use in ophthalmic settings.

  • Are there different sizes or models of the FlexSol Daily Cleaning Solution?

    The provided data does not specify multiple sizes or models for the FlexSol Daily Cleaning Solution. It is described as a single-use product under the trade name *PREFLEX DAILY CLEANING SOLN FOR SENSITIVE EYES*, implying a standardized formulation for home use.

  • How should the FlexSol Daily Cleaning Solution be stored to maintain its efficacy?

    While specific storage instructions are not detailed in the data, the product is sterile and intended for single-use. To maintain sterility and efficacy, it should be stored according to the manufacturer’s guidelines, typically in a cool, dry place away from direct sunlight and protected from contamination until use.