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FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K242513

by Guangdong Optomedic Technologies, Inc.

Identifiers

510(k) Number
K242513 FDA 510(k)
FDA Product Code
GCJ FDA 510(k)
Models / Variants
OPTO-CAM214K FDA 510(k)
OPTO-CHD214KE FDA 510(k)
OPTOCHD214KH FDA 510(k)
OPTO-LED214K FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The FloNavi Endoscopic Fluorescence Imaging System is a diagnostic imaging device designed for real-time visible and near-infrared (NIR) fluorescence imaging during endoscopic procedures. It captures optical signals from endoscopic inputs to enhance visualization of tissues, particularly when combined with contrast agents like Indocyanine Green (ICG). This aids in identifying anatomical structures and pathological areas during minimally invasive surgeries, such as those in gastroenterology and urology.

The system is supplied as a reusable medical device and is intended for use in clinical settings where fluorescence imaging enhances procedural guidance. It operates under FDA 510(k) clearance (K242513) and is classified under product code GCJ, reviewed by the Gastroenterology and Urology advisory committee. No specific sterility or MRI safety information is provided in the available data, and the device is not described as single-use or disposable.

Frequently asked questions

What is the FloNavi Endoscopic Fluorescence Imaging System used for?

The FloNavi Endoscopic Fluorescence Imaging System is designed for real-time visible and near-infrared (NIR) fluorescence imaging during endoscopic procedures. It enhances visualization of tissues by capturing optical signals, particularly when combined with contrast agents like Indocyanine Green (ICG). This aids clinicians in identifying anatomical structures and pathological areas, improving guidance during minimally invasive surgeries in fields such as gastroenterology and urology.

How is the FloNavi system supplied and intended for use?

The FloNavi Endoscopic Fluorescence Imaging System is supplied as a reusable medical device. It is intended for clinical use in settings where fluorescence imaging can improve procedural accuracy, such as operating rooms or endoscopy suites. The reusable nature allows for repeated use across multiple procedures, provided proper cleaning and maintenance protocols are followed.

Does the FloNavi system include any specific sterility or single-use requirements?

The available data does not specify whether the FloNavi system is sterile upon delivery or if it requires sterilization before use. Additionally, there is no mention of the device being single-use or disposable. Users should follow manufacturer guidelines for cleaning, disinfection, and sterilization to ensure safe reuse in clinical settings.

What models or references are included in the FloNavi Endoscopic Fluorescence Imaging System?

The FloNavi Endoscopic Fluorescence Imaging System includes four distinct models or references: OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, and OPTO-LED214K. These variations may differ in specific features or configurations, but all serve the same core purpose of fluorescence imaging during endoscopic procedures.

What regulatory pathway does the FloNavi system follow?

The FloNavi Endoscopic Fluorescence Imaging System has obtained FDA 510(k) clearance under the classification of product code GCJ, reviewed by the Gastroenterology and Urology advisory committee. The clearance decision was based on a determination of substantial equivalence to a predicate device, and the system is classified under the traditional 510(k) pathway.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO ..., FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO ..., FloNavi Endoscopic Fluorescence Imaging... (K242513) - FDA 510(k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Guangdong Optomedic Technologies, Inc.

Sources (1)

  • FDA 510(k) K242513 24 fields · synced Oct 1, 2026