FDA 510(k) Applications Submitted by Guangdong OptoMedic Technologies, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K230407 |
02/15/2023 |
FloNavi Open Field Fluorescence Imaging System |
Guangdong OptoMedic Technologies, Inc. |
| K221781 |
06/21/2022 |
Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH |
Guangdong OptoMedic Technologies, Inc. |
| K221861 |
06/27/2022 |
FloNavi Endoscopic Fluorescence Imaging System |
Guangdong OptoMedic Technologies, Inc. |
| K241530 |
05/30/2024 |
Stellar Imaging System |
Guangdong OptoMedic Technologies, Inc. |
| K231003 |
04/07/2023 |
Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC) |
Guangdong OptoMedic Technologies, Inc. |
| K231342 |
05/09/2023 |
Insufflator (OPTO-IFL1000) |
Guangdong OptoMedic Technologies, Inc. |
| K242513 |
08/23/2024 |
FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) |
Guangdong OptoMedic Technologies, Inc. |
|
|
