Medical Device Manufacturer · CN , Foshan

Guangdong Optomedic Technologies, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2023
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Guangdong Optomedic Technologies, Inc. General & Plastic Surgery ✕
7 devices
1-7 of 7
Cleared Oct 29, 2025
3D Laparoscope
K252697 · GCJ
General & Plastic Surgery · 63d
Cleared Oct 23, 2024
FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE,...
K242513 · GCJ
General & Plastic Surgery · 61d
Cleared Aug 07, 2024
Stellar Imaging System
K241530 · GCJ
General & Plastic Surgery · 69d
Cleared Jul 17, 2023
FloNavi Open Field Fluorescence Imaging System
K230407 · OWN
General & Plastic Surgery · 152d
Cleared Jul 06, 2023
Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA,...
K231003 · GCJ
General & Plastic Surgery · 90d
Cleared Feb 18, 2023
FloNavi Endoscopic Fluorescence Imaging System
K221861 · GCJ
General & Plastic Surgery · 236d
Cleared Feb 02, 2023
Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH
K221781 · GCJ
General & Plastic Surgery · 226d
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