Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027499529

FEI Number

3027499529

Entity Name

VISUSCIENCE MEDITECH CO., LTD.

City/State/Country

WUXI Jiangsu, CN

Establishment Address

Room 501,503 Ruiyun 5 No. 99 Furongzhongsan Rd.,, WUXI Jiangsu 214192, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

VisuScience Meditech Co., Ltd. (Owner Number: 10088752)

Owner / Operator Contact Address

Room 501,503 Ruiyun 5 No. 99 Furongzhongsan Rd.,, WUXI, CN-JS 214192, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Headlight Loupes VHL-100, VHL-200, VHL-300, VHL-100D iFlo Dry Eye Mask, USB Heating Eye Mask Slit Lamp Microscope SL1911D, VSL-120, VSL-130, VSL-150, VSL-190, VSL-520, VSL-530, VSL-550, VSL-590, VSL-100, VSL-200 VEC-100 EyeStream Eye Imaging Camera VMC-100 MeiboVue Meibomian Gland Imaging Camera

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HJH	Loupe, Binocular, Low Power	Ophthalmic	Class 1	886.5120	2024-11-29
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2024-11-29
PUE	Biomicroscope, Slit-Lamp, Ac-Powered, Exempt	Ophthalmic	Class 2	886.1850	2023-10-11
HMF	Stand, Instrument, Ac-Powered, Ophthalmic	Ophthalmic	Class 1	886.1860	2023-10-11
PJZ	Camera, Ophthalmic, General-Use	Ophthalmic	Class 2	886.1120	2023-10-07

Official Correspondent

Aaron Hong

US Agent Details

Mark Newkirk Email: marknewk@gmail.com Phone: (330) 9983786

Related Public Records

Same Entity

VisuScience Meditech 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
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

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3013846070	GREENS SURGICALS PRIVATE LIMITED	Vadodara Gujarat, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027499529. Last updated year: 2026. Please use registration number 3027499529 when referencing this establishment in official correspondence.