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Guangdong Optomedic Technologies, Inc. FDA Approvals
0 new drug approvals and 9 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Insufflator (OPTO-IFL1000)510(k)Apr 16, 2026Obstetrics/Gynecology |
| 3D Laparoscope510(k)Oct 29, 2025Gastroenterology, Urology |
| FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)510(k)Oct 23, 2024Gastroenterology, Urology |
| Stellar Imaging System510(k)Aug 7, 2024Gastroenterology, Urology |
| Insufflator (OPTO-IFL1000)510(k)Sep 20, 2023Obstetrics/Gynecology |
| FloNavi Open Field Fluorescence Imaging System510(k)Jul 17, 2023Gastroenterology, Urology |
| Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)510(k)Jul 6, 2023Gastroenterology, Urology |
| FloNavi Endoscopic Fluorescence Imaging System510(k)Feb 18, 2023Gastroenterology, Urology |
| Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH510(k)Feb 2, 2023Gastroenterology, Urology |