Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043512

FEI Number

3002807701

Entity Name

NEITZ INSTRUMENTS COMPANY, LTD.

City/State/Country

CHIYODA-KU Tokyo, JP

Establishment Address

4F ICHIBANCHO COURT, 15-21, ICHIBANCHO,, CHIYODA-KU Tokyo 102-0082, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NEITZ INSTRUMENTS CO.LTD. (Owner Number: 9002089)

Owner / Operator Contact Address

4F ICHIBANCHO COURT, 15-21, ICHIBANCHO, CHIYODA-KU, JP-13 102-0082, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IO-a; IO-a LED Neitz Contact Gauge CGX-3 LED, CGX-4 LED; Neitz Contact Gauge CGX-3, CGX-4 NEITZ ANOMALOSCOPE Anomaloscope OT-II OPHTHALMOSCOPE, AC-POWERED A COMPONENT OF HALOGEN DIAGNOSTIC S; BXX-12345; ET BXX-12345 RX-3, RX-3A, RX-RC, RX-3SP, RX-3ASP, RX-RCSP, RX3LED, RX3ALED, RX3SPLED, RX3ASPLED MULTIPLE RXRCLED, RXRCSPLED, RXRCUSBLED, RXRCUSBSPLED FO A COMPONENT OF HALOGEN DIAGNOSTIC SET BX-12345FO; BX-134FO -34FO Otoscope -34FO Otoscope FO IO-a LED; IO-a LED CAMERA IO- LED, IO- LED CAMERA DOCTOR LIGHT DL; MEDICOSPOT MS Halogen Medicospot MS-H BXa-13, BXa-13A, BXa-RC, BXa13LED, BXa13ALED, BX?13RXLED, BX?13ARXLED, BX?13RXSPLED, BX?13ARXSPLED Neitz Halogen Ophthalmoscope BXa-13 BXPlus-13, BXPlus-13A BXaRCLED, BXaRCUSBLED, BXaRCRXLED,BXaRCUSBRXLED BXa-13, BXa-13A, BXa-RC, BXa13LED, BXa13ALED, BXa13RXLED, BXa13ARXLED, BXa13RXSPLED, BXa13ARXSPLED HALOGEN OPHTHALMO-O Halogen Ophthalmoscope BXa-RC TBLS-2S, TBLS-2N BLS-1, BLS-2, BLS-3, BLD-3, BLP-4, BLP-6 TBLS-2, TBLD-3, TBLP-4 LOUPE, BINOCULAR, LOW POWER BTL-2S, BTL-2N

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HLI	Ophthalmoscope, Ac-Powered	Ophthalmic	Class 2	886.1570	2013-09-19
HLF	Device, Measuring, Lens Radius, Ophthalmic	Ophthalmic	Class 1	886.1430	1995-04-28
HIW	Anomaloscope	Ophthalmic	Class 1	886.1070	1995-04-28
HLI	Ophthalmoscope, Ac-Powered	Ophthalmic	Class 2	886.1570	2015-10-23
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	1995-06-28
HKM	Retinoscope, Battery-Powered	Ophthalmic	Class 1	886.1780	1995-04-13
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	1995-05-17
HLJ	Ophthalmoscope, Battery-Powered	Ophthalmic	Class 2	886.1570	2018-10-28
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	1994-05-26
HLJ	Ophthalmoscope, Battery-Powered	Ophthalmic	Class 2	886.1570	2015-09-07
HJL	Lens, Condensing, Diagnostic	Ophthalmic	Class 1	886.1380	1995-06-09
HLI	Ophthalmoscope, Ac-Powered	Ophthalmic	Class 2	886.1570	2015-10-23
HJH	Loupe, Binocular, Low Power	Ophthalmic	Class 1	886.5120	1994-05-26

Official Correspondent

Takashi Terui

US Agent Details

Mindy McCann Business: Qserve Group US, Inc. Email: USagent@Qservegroup.com Phone: (424) 2718169

Related Public Records

Same Entity

NEITZ INSTRUMENTS 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
K142953	Optomedical Technologies GmbH	OCT-Camera	2015-03-04
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08

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
1226587	HAI LABORATORIES, INC.	LEXINGTON, MA, US
3003882387	B. ALI IMPEX	SIALKOT, Punjab, PK
3010000450	CRYSTALVUE MEDICAL CORPORATION	Taoyuan Dist.,, TW
1000379039	HEINE OPTOTECHNIK GMBH & CO. KG.	GILCHING Bavaria, DE
3013298431	VEENAK INTERNATIONAL LIMITED	BIRMINGHAM, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043512. Last updated year: 2026. Please use registration number 8043512 when referencing this establishment in official correspondence.