# K242513: FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K,  OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Optomedic Technologies, Inc.
- Decided: Oct 23, 2024 after 61 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Upon intravenous administration and use of an ICG consistent with its approved label, the FloNavi Endoscopic Fluorescence Imaging System is intended to provide real time endoscopic visible and near-infrared fluorescence imaging. During minimally invasive surgery, the FloNavi Endoscopic Fluorescence Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts, using near-infrared imaging. Upon interstitial administration and use of an ICG consistent with its approved label, the FloNavi Endoscopic Fluorescence Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Source page: https://510kreport.com/device/K242513
Methodology: https://510kreport.com/methodology