Skip to content

U.C.E.Z. Lens Cleaner Kit

by Anago, Inc.

510(k) K925659

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK925659 Date17 Sep 1993ClearedStatusActive

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  • Withdrawn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 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OCT
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 U.C.E.Z. Lens Cleaner Kit is a device designed for cleaning lenses, likely used in medical or optical applications. It is classified as an anti-fog solution and accessories for endoscopy, with a focus on gastroenterology and urology.

The device is supplied as a kit and is intended for single-use. It is regulated under FDA 510(k) clearance (K925659) and is not reusable. The manufacturer, Anago, Inc., is based in Fort Worth, Texas, and the device is not MRI safe.

Other devices from Anago, Inc.

See all devices from Anago, Inc. →

Questions

AI-generated answers, 25 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 U.C.E.Z. Lens Cleaner Kit used for?

    This kit is designed to clean lenses and prevent fogging, specifically for use in medical and optical applications within gastroenterology and urology.

  • Is the U.C.E.Z. Lens Cleaner Kit reusable?

    No, the device is intended for single-use and is not reusable to maintain hygiene and performance standards.

  • How is the U.C.E.Z. Lens Cleaner Kit supplied?

    It is supplied as a kit containing anti-fog solution and necessary accessories for cleaning lenses.

  • What is the regulatory status of the U.C.E.Z. Lens Cleaner Kit?

    The device is regulated under FDA 510(k) clearance (K925659) and is classified as a Class II medical device.