Data / Medical devices / China / Guangdong Optomedic Technologies, Inc.
Guangdong Optomedic Technologies, Inc.: FDA-registered device maker in Foshan Guangdong, China, 9 510(k) clearances
Guangdong Optomedic Technologies, Inc. is registered with the FDA (registration 3029968414) in Foshan Guangdong, China. It lists 7 device types. The FDA files 9 510(k) clearances under its listings, the newest dated April 16, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029968414
- Address
- Suite 503, Building A, Golden Valley Intellicreation Community No. 2 Yonganbei Street, Daxu, Guicheng,Nanhai, Foshan Guangdong, China, 528200
- Owner or operator
- Guangdong OptoMedic Technologies, Inc. (10088815)
- Roles
- Manufacturer
- First device listed
- October 13, 2023
- Registered through
- 2026
- Brand names listed
- 3D Laparoscope: 21033SA,21033SC, 3D Laparoscope: 21050SA, 21050SC, Endoscopic Camera System OPTO-CAM104K, OPTO-CHD104KH, Endoscopic Fluorescence lmaging System 71-068-05 NIR-CA, 71-068-10 NIR-CA, 71-068-20 NIR-CA,71-182-30 NIR-CA, Endoscopic Fluorescence lmaging System 71-182-30 NIR, 71-068-05 NIR, 71-068-10 NIR, 71-068-20 NIR, FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K), FloNavi Endoscopic Fluorescence Imaging System OPTO-CAM2100, OPTO-CHD2100, OPTO-LED2100, FloNavi Endoscopic Fluorescence Imaging System OPTO-CAM214K, OPTO-CHD214KE, OPTO-CHD214KH, OPTO-LED214K and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Confocal Optical Imaging | OWN | 2 | Manufacturer | accessdata.fda.gov |
| Insufflator, Laparoscopic | HIF | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscope And Accessories, Gynecologic, Reprocessed | NMH | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscope, Gynecologic (And Accessories) | HET | 2 | Manufacturer | accessdata.fda.gov |
| Led Light Source | NTN | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Angiographic | IZI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 16, 2026 | K252318 | Insufflator (OPTO-IFL1000) | HIF | Substantially Equivalent | Guangdong Optomedic Technologies, Inc. | accessdata.fda.gov |
| October 29, 2025 | K252697 | 3D Laparoscope | GCJ | Substantially Equivalent | Guangdong Optomedic Technologies, Inc. | accessdata.fda.gov |
| October 23, 2024 | K242513 | FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) | GCJ | Substantially Equivalent | Guangdong Optomedic Technologies, Inc. | accessdata.fda.gov |
| August 7, 2024 | K241530 | Stellar Imaging System | GCJ | Substantially Equivalent | Guangdong Optomedic Technologies, Inc. | accessdata.fda.gov |
| September 20, 2023 | K231342 | Insufflator (OPTO-IFL1000) | HIF | Substantially Equivalent | Guangdong Optomedic Technologies, Inc. | accessdata.fda.gov |
| July 17, 2023 | K230407 | FloNavi Open Field Fluorescence Imaging System | OWN | Substantially Equivalent | Guangdong Optomedic Technologies, Inc. | accessdata.fda.gov |
| July 6, 2023 | K231003 | Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC) | GCJ | Substantially Equivalent | Guangdong Optomedic Technologies, Inc. | accessdata.fda.gov |
| February 18, 2023 | K221861 | FloNavi Endoscopic Fluorescence Imaging System | GCJ | Substantially Equivalent | Guangdong Optomedic Technologies, Inc. | accessdata.fda.gov |
| February 2, 2023 | K221781 | Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH | GCJ | Substantially Equivalent | Guangdong Optomedic Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Insufflator, Laparoscopic
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Led Light Source
- All makers of Confocal Optical Imaging
- All makers of System, X-Ray, Angiographic
- All makers of Laparoscope And Accessories, Gynecologic, Reprocessed
Updated April 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.