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Visera Elite III Video System Center Olympus Otv-S700; Visera Elite III LED Light Source Olympus Cll-S700; 4K Camera Head Olympus Ch-S700-Xz-Ea

by Olympus Corporations of the Americas

510(k) K242067

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 NumberK242067 Date2 Apr 2025ClearedStatusActive

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  • Withdrawn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
FET
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Visera Elite III is an endoscopic visualization platform that includes a video system center, LED light source, and 4K camera head. It is designed for use in gastroenterology and urology procedures, providing high-quality imaging with 4K resolution for detailed visualization of tissues and structures.

The system is supplied as a complete imaging platform with components including the video system center, LED light source, and 4K camera head. It is intended for use in clinical settings and is regulated as a Class II medical device with FDA 510(k) clearance. The system is designed to be backward compatible and supports software upgrades to help reduce future costs.

Other devices from Olympus Corporation of the Americas

Questions

AI-generated answers, 24 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 Visera Elite III system used for?

    The Visera Elite III is an endoscopic visualization platform designed for use in gastroenterology and urology procedures. It provides high-quality 4K imaging for detailed visualization of tissues and structures during medical procedures.

  • What components are included in the Visera Elite III system?

    The system is supplied as a complete imaging platform with three main components: the video system center (OTV-S700), LED light source (CLL-S700), and 4K camera head (CH-S700-XZ-EA). These components work together to provide comprehensive endoscopic visualization capabilities.

  • Is the Visera Elite III system reusable or single-use?

    The Visera Elite III system is designed for multiple uses in clinical settings. It is a reusable platform that supports software upgrades to help reduce future costs, though individual components may have specific reuse guidelines that should be followed according to manufacturer instructions.

  • What is the regulatory status of the Visera Elite III system?

    The Visera Elite III system is regulated as a Class II medical device with FDA 510(k) clearance. It received a traditional clearance with a decision code of SESE (Substantially Equivalent) and is intended for use in gastroenterology and urology procedures.