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Jsz-Multipurpose Solution

by Szabocsik and Associates 510(k)

Active United States

510(k) K050517

Overview

The JSZ Multipurpose Solution is a sterile, isotonic chemical solution designed for the maintenance of soft (hydrophilic) contact lenses. It is classified as an accessory under soft lens products and contains poloxamer, sodium phosphate buffer, sodium chloride, disodium edetate, and polyhexanide (0.0001%) as a preservative, excluding chlorhexidine and thimerosal.

This solution is intended for use in ophthalmic settings and is supplied in a sterile, single-use format. It adheres to FDA regulation 886.5928 and has received a Substantially Equivalent (SESE) clearance under 510(k) K050517. The product is classified as a Class II medical device and is regulated under the Ophthalmic Device review panel.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK050517 Date13 Apr 2005ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

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Questions

  • What is the JSZ Multipurpose Solution primarily used for in clinical settings?

    The JSZ Multipurpose Solution is designed specifically for the maintenance of soft (hydrophilic) contact lenses in ophthalmic settings. It is formulated to clean, disinfect, and store these lenses safely, ensuring they remain in optimal condition for patient use.

  • Is the JSZ Multipurpose Solution sterile and single-use, or is it intended for reuse?

    The JSZ Multipurpose Solution is supplied in a sterile, single-use format, meaning each unit is intended for one-time use only. This ensures hygiene and reduces the risk of contamination during lens care.

  • What key ingredients are included in the JSZ Multipurpose Solution, and why are they important?

    The solution contains poloxamer for lens conditioning, sodium phosphate buffer to maintain isotonicity, sodium chloride for electrolyte balance, disodium edetate as a chelating agent, and polyhexanide (0.0001%) as a preservative—excluding chlorhexidine and thimerosal—helping to ensure effective cleaning and disinfection without harsh preservatives.

  • How is the regulatory status of this product determined, and what does that mean for clinicians?

    The JSZ Multipurpose Solution received a Substantially Equivalent (SESE) clearance under FDA 510(k) K050517, meaning it was deemed comparable to a legally marketed predicate device. Clinicians can rely on its compliance with FDA standards for soft lens accessories, ensuring safety and efficacy in ophthalmic use.

  • What storage or handling considerations should be taken into account for the JSZ Multipurpose Solution?

    Since the solution is sterile and single-use, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Once opened, it should be used immediately to maintain sterility, as reuse is not intended.