Guangdong Optomedic Technologies, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 8
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252697 | 3D Laparoscope | October 29, 2025 |
| K242513 | FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED | October 23, 2024 |
| K241530 | Stellar Imaging System | August 7, 2024 |
| K231342 | Insufflator (OPTO-IFL1000) | September 20, 2023 |
| K230407 | FloNavi Open Field Fluorescence Imaging System | July 17, 2023 |
| K231003 | Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC) | July 6, 2023 |
| K221861 | FloNavi Endoscopic Fluorescence Imaging System | February 18, 2023 |
| K221781 | Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH | February 2, 2023 |