Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004095901

FEI Number

3004095901

Entity Name

LIANYUNGANG TIANNUO OPTICAL INSTRUMENT CO., LTD.

City/State/Country

LIANYUNGANG Jiangsu, CN

Establishment Address

No.3 Jinqiao Road, Dapu Industrial Park,, LIANYUNGANG Jiangsu 222000, CN

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

LIANYUNGANG TIANNUO OPTICAL INSTRUMENT CO., LTD. (Owner Number: 9057405)

Owner / Operator Contact Address

No.3 Jinqiao Road,, Dapu Industrial Park,-, LIANYUNGANG, CN-JS 222069, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K142263

PMA Number

N/A

All Registered Proprietary Names

Ophthalmic Prism Bar Slit Lamp Vision Chart Ophthalmoscope Slit Lamp glasses frame, spectacle frame Lens Clock Radian Aparatus MANUAL OPHTHALMOLOGY PUPILLOMETER PROJECTOR INCLUDING PHOROPTER OPHTHALMOLOGY REFRACTOR SIMULATAN (INCLUDING CROSS Retinoscope OPHTHALMIC#OPHTHALMOLOGY REFRACTOMETER Confirmation Test 1. Portable Slit Lamp Microscope, Model: BL-5000, BL-5100 Ophthalmoscope Battery-powered direct ophthalmoscopes STAND EXOPHTHALMOMETER Occluder Ophthalmoscope, Ac-Powered Indirect Ophthalmoscope OPHTHALMIC#OPHTHALMOLOGY TRIAL Lensometer Keratometer HKY - Tonometer, manual

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HKW	Prism, Bar, Ophthalmic	Ophthalmic	Class 1	886.1650	2009-04-09
HJO	Biomicroscope, Slit-Lamp, Ac-Powered	Ophthalmic	Class 2	886.1850	2014-08-20
HOX	Chart, Visual Acuity	Ophthalmic	Class 1	886.1150	2010-11-09
MSG	Ophthalmoscopes, Replacement Batteries, Hand-Held	Ophthalmic	Class 2	886.1570	2018-03-27
HJO	Biomicroscope, Slit-Lamp, Ac-Powered	Ophthalmic	Class 2	886.1850	2014-08-20
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2018-03-27
HLN	Gauge, Lens, Ophthalmic	Ophthalmic	Class 1	886.1420	2014-04-21
HLH	Pupillometer, Manual	Ophthalmic	Class 1	886.1700	2005-03-30
HOS	Projector, Ophthalmic	Ophthalmic	Class 1	886.1680	2006-03-10
HKN	Refractor, Manual, Non-Powered, Including Phoropter	Ophthalmic	Class 1	886.1770	2006-03-10
HOR	Simulatan (Including Crossed Cylinder)	Ophthalmic	Class 1	886.1840	2005-03-11
HKM	Retinoscope, Battery-Powered	Ophthalmic	Class 1	886.1780	2009-11-30
HKO	Refractometer, Ophthalmic	Ophthalmic	Class 1	886.1760	2003-07-14
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2010-10-21
PUE	Biomicroscope, Slit-Lamp, Ac-Powered, Exempt	Ophthalmic	Class 2	886.1850	2026-02-26
HLJ	Ophthalmoscope, Battery-Powered	Ophthalmic	Class 2	886.1570	2021-11-10
HMF	Stand, Instrument, Ac-Powered, Ophthalmic	Ophthalmic	Class 1	886.1860	2006-03-10
HLS	Exophthalmometer	Ophthalmic	Class 1	886.1270	2010-12-27
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2013-11-21
HLI	Ophthalmoscope, Ac-Powered	Ophthalmic	Class 2	886.1570	2021-11-10
HPC	Set, Lens, Trial, Ophthalmic	Ophthalmic	Class 1	886.1405	2003-07-14
HLM	Instrument, Measuring, Lens, Ac-Powered	Ophthalmic	Class 1	886.1425	2009-04-09
HLQ	Keratoscope, Ac-Powered	Ophthalmic	Class 1	886.1350	2014-08-18
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2017-01-23

Official Correspondent

No official correspondent registered.

US Agent Details

RONG ZHANG Business: HORTRON ENTERPRISE, INC. Email: HORTRONOPTICAL@YAHOO.COM Phone: (909) 9887328

Related Public Records

Same Entity

LIANYUNGANG TIANNUO OPTICAL INSTRUMENT 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
K910951	United Optical, Spa	OPTHLAMIC FRAMES	1991-05-06
K142953	Optomedical Technologies GmbH	OCT-Camera	2015-03-04
K900478	Woodlyn, Inc.	WOODLYN FULL APERTURE TRIAL LENS SET	1990-02-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2018	Optovue, Inc.	2	iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue with Normative Database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
Z-0010-2018	Optovue, Inc.	2	iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normative database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue 500 with normative database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.

Similar Registrations

Registration Number	Establishment Name	Location
3003860739	MEDI INSTRUMENTS INC.	Scarsdale, NY, US
3009275598	WUXI ZONTAI INT'L CORPORATION LTD.	WUXI Jiangsu, CN
2518410	GULDEN OPHTHALMICS	Elkins Park, PA, US
3006550126	SPEEDWAY	India Delhi, IN
3003951061	M/S TARUN ENTERPRISES	Prayagraj, Uttar Pradesh, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004095901. Last updated year: 2026. Please use registration number 3004095901 when referencing this establishment in official correspondence.