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Jsz-Stat-Tree, and Jsz-Stat-or, Cleaning, Disinfecting and Storing Solutions; Jsz-Wet-Tree and Jsz-Wet-or, Wetting,

by Szabocsik and Associates

510(k) K052074

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK052074 Date1 Sep 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
MRC
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 886.5918
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 JSZ-Stat-Tree and JSZ-Stat-Or Cleaning, Disinfecting and Storing Solutions; and JSZ-Wet-Tree and JSZ-Wet-Or Wetting Solutions are chemical formulations designed for rigid gas permeable (RGP) contact lens care. These solutions are intended for the cleaning, chemical disinfection, and storage of fluoro/silicone acrylate and silicone acrylate contact lenses, while the wetting solutions provide lubrication and rewetting for lens wearers.

These solutions are supplied as sterile, single-use or reusable formulations depending on the specific product variant, adhering to FDA 510(k) clearance under regulation 21 CFR 886.5918. They are classified as Class II medical devices under product code MRC and are intended for ophthalmic use. Storage conditions and handling instructions are detailed in the accompanying documentation, ensuring proper maintenance of sterility and efficacy.

Other devices from Szabocsik and Associates

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 are the JSZ-Stat-Tree and JSZ-Stat-Or solutions used for?

    These solutions are specifically designed for the cleaning, chemical disinfection, and storage of rigid gas permeable (RGP) contact lenses, including fluoro/silicone acrylate and silicone acrylate materials. They help maintain lens hygiene and extend lens life.

  • Are these solutions single-use or reusable?

    The JSZ solutions are supplied as both sterile single-use and reusable formulations depending on the specific product variant. Users should follow the accompanying documentation for proper handling instructions to maintain sterility and efficacy.

  • What types of contact lenses are compatible with these solutions?

    These solutions are specifically formulated for rigid gas permeable (RGP) contact lenses, including those made of fluoro/silicone acrylate and silicone acrylate materials. They are not intended for use with soft contact lenses.

  • What is the regulatory status of these solutions?

    The JSZ-Stat-Tree and JSZ-Stat-Or solutions have received FDA 510(k) clearance under regulation 21 CFR 886.5918. They are classified as Class II medical devices under product code MRC and are intended for ophthalmic use.