# Guangdong Optomedic Technologies, Inc.

- Location (FDA's records): Foshan, CN
- FDA decisions: 9 (2023–2026): 9 510(k) clearances
- Product codes: GCJ (6), HIF (2), OWN (1)
- 510(k) review time since 2016: median 134 days, against 109 for FDA's reviews in the same codes and years (4 of 9 faster)
- Predicates its devices cite: 9 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- KARL STORZ Endoscopy-America, Inc.: 2 (https://510kreport.com/company/karl-storz-endoscopy-america)
- Novadaq Technologies Ulc. (Now A Part of Stryker): 2 (https://510kreport.com/company/novadaq-technologies-ulc-now-a-part-of-stryker)
- Omec Medical, Inc.: 1 (https://510kreport.com/company/omec-medical)
- W.O.M. World of Medicine GmbH: 1 (https://510kreport.com/company/wom-world-of-medicine)
- Scivita Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/scivita-medical-technology)

## Its most-cited devices
- K241530: Stellar Imaging System (2024), cited by 1
- K221861: FloNavi Endoscopic Fluorescence Imaging System (2023), cited by 1

## Recent decisions
- K252318: Insufflator (OPTO-IFL1000) (Apr 16, 2026)
- K252697: 3D Laparoscope (Oct 29, 2025)
- K242513: FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K,  OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) (Oct 23, 2024)
- K241530: Stellar Imaging System (Aug 7, 2024)
- K231342: Insufflator (OPTO-IFL1000) (Sep 20, 2023)
- K230407: FloNavi Open Field Fluorescence Imaging System (Jul 17, 2023)
- K231003: Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC) (Jul 6, 2023)
- K221861: FloNavi Endoscopic Fluorescence Imaging System (Feb 18, 2023)

Source page: https://510kreport.com/company/guangdong-optomedic-technologies