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Confocal Microprobe Imaging System - Confocal Microprobe Imaging System (BrightP660)

by Wuxi Hisky Medical Technologies Co., Ltd.

510(k) K243711

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K243711↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK243711 Date24 Jul 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
OWN
Models / Variants
Confocal Microprobe Imaging System (BrightP660)
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Confocal Microprobe Imaging System is a confocal optical imaging device designed for high-resolution, in vivo microscopic imaging. It provides real-time visualization of tissue structures at the cellular level, enabling detailed examination of biological samples during procedures in gastroenterology and urology.

The system is supplied as a reusable medical device and is intended for use in clinical settings where MRI safety is not a concern. Models vary by reference code (BrightP580 through BrightP980) and are regulated under FDA 510(k) clearance, MDD, and MDR compliance. Sterility and single-use status are not specified; storage and handling follow standard medical device protocols as defined by the manufacturer.

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Questions

AI-generated answers, 18 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 clinical specialties is the Confocal Microprobe Imaging System primarily used in, and how does this relate to its design?

    The Confocal Microprobe Imaging System is designed for use in gastroenterology and urology, as indicated by its advisory committee classification and medical specialty descriptions. Its high-resolution, in vivo microscopic imaging capability enables real-time visualization of tissue structures at the cellular level, making it particularly useful for detailed examinations during procedures in these specialties, such as endoscopic or urological assessments.

  • Are the different models (BrightP580 through BrightP980) interchangeable, and if so, how might they differ?

    The models BrightP580 through BrightP980 are distinct variants of the same core device, but their specific differences (e.g., imaging resolution, probe size, or software features) are not detailed in the provided data. While they share the same regulatory framework and intended use, they may be optimized for different procedural needs or imaging depths. Consult the manufacturer’s documentation for model-specific technical specifications.

  • How should the Confocal Microprobe Imaging System be stored and handled, given it is described as reusable?

    As a reusable medical device, the Confocal Microprobe Imaging System must follow standard medical device protocols for storage and handling, including cleaning, disinfection, and sterilization procedures as outlined by the manufacturer. Since sterility and single-use status are not specified, proper maintenance is critical to ensure safety, functionality, and compliance with clinical standards. Always refer to the manufacturer’s instructions for detailed protocols.

  • What regulatory pathways does the Confocal Microprobe Imaging System follow, and how does this affect its use in clinical settings?

    The system is regulated under FDA 510(k) clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation) compliance. This means it has undergone evaluation for safety and performance in its intended clinical applications (gastroenterology and urology) and must meet the respective regulatory standards of the regions where it is used. Clinicians should ensure the device is used within its approved indications and adheres to local regulatory requirements.

  • Can this device be used in conjunction with MRI procedures, and if not, why is that specified?

    No, the Confocal Microprobe Imaging System is not intended for use in MRI environments. The device’s design does not account for MRI safety concerns, meaning it should not be used in settings where MRI compatibility is required. This limitation is explicitly noted in the device description to prevent potential interference or safety risks in such clinical contexts.