Data / Medical devices / China / Shenzhen Vivolight Medical Device&technology Co., Ltd.
Shenzhen Vivolight Medical Device&technology Co., Ltd.: FDA-registered device maker in shenzhen Guangdong, China, 1 510(k) clearance
Shenzhen Vivolight Medical Device&technology Co., Ltd. is registered with the FDA (registration 3013351723) in shenzhen Guangdong, China. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 11, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013351723
- Address
- Room 511-A, 5th Floor, Block B, Building R2, High-tech Industrial Park, No. 020, South Seventh Road Gaoxin Community, Yuehai Street, Nanshan District, shenzhen Guangdong, China, 518063
- Owner or operator
- Shenzhen Vivolight Medical Device&Technology Co., Ltd. (10054042)
- Roles
- Manufacturer
- First device listed
- February 6, 2017
- Registered through
- 2026
- Brand names listed
- Cornaris Intravascular Imaging System (Mobile-E), Cornaris Intravascular Imaging System (P80-E), LumenCross Imaging Catheter (F2), MICROSCOPE, SURGICAL, Vglasses A Vessel navigation glasses, MICROSCOPE, SURGICAL, Vglasses Pro Vessel navigation glasses, MICROSCOPE, SURGICAL, Vglasses V Vessel navigation glasses, SV800P Projection Vein Finder, V800F Projection Vein Finder and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Diagnostic | DQO | 2 | Manufacturer | accessdata.fda.gov |
| Device, Vein Location, Liquid Crystal | KZA | 1 | Manufacturer | accessdata.fda.gov |
| Microscope, Surgical, General & Plastic Surgery | FSO | 1 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Optical Coherence Tomography (Oct) | NQQ | 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 11, 2025 | K242098 | Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) | NQQ | Substantially Equivalent | Shenzhen Vivolight Medical Device & Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Microscope, Surgical, General & Plastic Surgery
- All makers of Device, Vein Location, Liquid Crystal
- All makers of Catheter, Intravascular, Diagnostic
- All makers of System, Imaging, Optical Coherence Tomography (Oct)
Updated April 11, 2025. 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.