Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013351723

FEI Number

3013351723

Entity Name

SHENZHEN VIVOLIGHT MEDICAL DEVICE&TECHNOLOGY CO., LTD.

City/State/Country

shenzhen Guangdong, CN

Establishment 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 518063, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Vivolight Medical Device&Technology Co., Ltd. (Owner Number: 10054042)

Owner / Operator Contact 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, CN-GD 518063, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MICROSCOPE, SURGICAL, Vglasses Pro Vessel navigation glasses MICROSCOPE, SURGICAL, Vglasses A Vessel navigation glasses MICROSCOPE, SURGICAL, Vglasses V Vessel navigation glasses LumenCross Imaging Catheter (F2) Cornaris Intravascular Imaging System (Mobile-E) Cornaris Intravascular Imaging System (P80-E) V900F Projection Vein Finder V900P Projection Vein Finder Vivo 500S Projection Vein Finder V800F Projection Vein Finder V800P Projection Vein Finder V800NV Projection Vein Finder SV800P Projection Vein Finder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSO	Microscope, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4700	2024-01-25
NQQ	System, Imaging, Optical Coherence Tomography (Oct)	Radiology	Class 2	892.1560	2025-05-18
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2025-05-18
KZA	Device, Vein Location, Liquid Crystal	General Hospital	Class 1	880.6970	2017-02-06

Official Correspondent

Pengyang Gao

US Agent Details

Anny zhao Business: Hlongmed International Ltd. Email: usagent@hlongmed.com Phone: (503) 3344880

Related Public Records

Same Entity

Shenzhen Vivolight Medical Device&Technology Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K183320	St. Jude Medical (Now Abbott Medical)	Ilumien Optis, Optis Integrated, Optis Mobile	2019-04-02
K253459	ABBOTT MEDICAL	OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)	2026-04-24
K210458	ABBOTT MEDICAL	OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System	2021-06-08
K151126	Colibri Technologies, Inc.	Foresight Intracardiac Echocardiography (ICE) System	2015-12-18
K931629	Carapace, Inc.	CARAPACE ANGIOGRAPHY TRAYS	1993-12-06

Similar Registrations

Registration Number	Establishment Name	Location
3014059828	SHANGHAI EDER MEDICAL TECHNOLOGY INC.	Shanghai, CN
3025436467	GAVIN BIOTECHNOLOGY CO.,LTD	Jinzhong Shanxi, CN
3013154160	Suzhou Semorr Medical Technology Co.,Ltd.	Suzhou Jiangsu, CN
3005527904	ATMOS INC.	Exton, PA, US
3001644167	Symmetry Surgical GmbH	TUTTLINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013351723. Last updated year: 2026. Please use registration number 3013351723 when referencing this establishment in official correspondence.