Optiscan Model Optiscan CEIS

by Optiscan Pty., Ltd.

510(k) K093624

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

510(k) K093624↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK093624	Date5 Mar 2010Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K093624
FDA Product Code: GCJ
FDA applicant: Optiscan Pty. , Ltd.

Device Class: Class II
Regulation: 21 CFR Part 876.1500
Advisory Committee: Gastroenterology, Urology
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Optiscan Confocal Endoscopic Imaging System (CEIS) provides confocal laser imaging of the internal microstructure of tissues accessed through video endoscopes equipped with a confocal laser imaging module. It is designed for use in gastrointestinal and urological procedures to visualize microscopic tissue detail in real time.

The system was cleared by the U.S. FDA through a traditional 510(k) submission (K093624) as substantially equivalent to a predicate device, with the decision issued on 5 March 2010. It is marketed by Optiscan Pty. Ltd. under product code GCJ and is intended for clinical use in the anatomical tracks accessed by legally marketed video endoscopes.