# K252697: 3D Laparoscope

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Optomedic Technologies, Inc.
- Decided: Oct 29, 2025 after 63 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
Longest line of descent: 20 generations back to K930667 (1994). 88 ancestors in all.
No later device cites it as a predicate yet.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241530: Stellar Imaging System, Guangdong Optomedic Technologies, Inc. (2024) Summary page 5.

## Indications for use
Stellar Imaging System is intended to provide real-time visible and near-infrared imaging in minimally invasive procedures. Upon intravenous administration and use of an ICG agent consistent with its approved label, Stellar Imaging System is used to perform fluorescence imaging visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts. Upon interstitial administration and use of an ICG agent consistent with its approved label, the Stellar 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/K252697
Methodology: https://510kreport.com/methodology