TOPCON CORP.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
9614661	1000175127	TOPCON CORP.	1	N	2027-01-01	75-1 HASUNUMA-CHO ITABASHI-KU TOKYO JP 174-8580

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
17321	1011239418	K871335	TOPCON COMPUTERIZED TONOMETER CT-10	HKX	1987-05-18
17321	1167683359	K262637	SLIT LAMP SL-D4 (Type: LED)	HJO	2026-09-18
17321	1755166880	K253039	AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA	HKX	2025-11-07
17321	1432251637	K241081	3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System	OBO	2024-07-17
17321	1593372338	K233561	3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))	OBO	2024-04-10
17321	1634200258	K232828	IMAGEnet6 Ophthalmic Data System	NFJ	2024-03-01
17321	1300531547	K221111	Non-Mydriatic Retinal Camera NW500	HKI	2022-08-29
17321	2004488009	K173119	DRI OCT Triton	OBO	2018-01-19
17321	1356917578	K171370	IMAGEnet 6 Ophthalmic Data System	NFJ	2017-11-01
17321	1273981238	K170164	3D OCT-1 Maestro	OBO	2017-03-03
17321	1736293145	K161972	Slit Lamp SL-D301	HJO	2016-12-09
17321	1120813149	K161509	3D OCT-1 Maestro	OBO	2016-07-28
17321	1137775439	K142417	SP-1PSpecular Microscope	NQE	2015-05-29
17321	1849064490	K141481	TRC-NW400 NON-MYDRIATIC RETINAL CAMERA	HKI	2014-09-17
17321	1392985473	K141325	TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA	HKI	2014-10-23
17321	1493483148	K133667	SLIT LAMP SL-D701	HJO	2014-08-26
17321	1667041865	K132438	IMAGENET 5 PC SOFTWARE SYSTEM	NFJ	2013-10-17
17321	1656127647	K130289	TRC-NW8 NON-MYDRIATIC RETINAL CAMERA	HKI	2013-05-10
17321	1342060805	K123460	TRC-NW300 NON-MYDRIATIC RETINAL CAMERA	HKI	2013-02-06
17321	2052836693	K123101	TRC-50DX RETINAL CAMERA	HKI	2013-06-05
17321	1972829797	K110489	SLIT LAMP SL-2G	HJO	2011-05-23
17321	1822383014	K100207	NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F	HKI	2010-02-12
17321	2070846606	K092470	OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000	OBO	2009-09-02
17321	1446332507	K090115	RETINA CAMERA TRC-NW7SF MARK II	HKI	2009-06-30
17321	1437359794	K083316	3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM	OBO	2009-03-13
17321	1509257176	K082364	IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR	NFJ	2008-09-30
17321	1443936887	K072971	TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS	OBO	2009-01-13
17321	2072467918
17321	1044450938
17321	1207414828
17321	1322436036
17321	1382162039
17321	1390328711
17321	1393082815
17321	1439037125
17321	1527578408
17321	1577859147
17321	1623553064
17321	1662558686
17321	1669925112
17321	1724391399
17321	1857612113
17321	1928922528
17321	1951919844
17321	2049109863
17321	2051934913

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
OBO	8	2024-07-17
HKI	8	2022-08-29
HJO	4	2026-09-18
NFJ	4	2024-03-01
HKX	2	2025-11-07
NQE	1	2015-05-29

PMN#

TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA
2014-10-23
TOPCON CORP.
SLIT LAMP SL-D701
2014-08-26
TOPCON CORP.
TRC-NW8 NON-MYDRIATIC RETINAL CAMERA
2013-05-10
TOPCON CORP.
NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F
2010-02-12
TOPCON CORP.
OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000
2009-09-02
TOPCON CORP.
RETINA CAMERA TRC-NW7SF MARK II
2009-06-30
TOPCON CORP.
IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR
2008-09-30
TOPCON CORP.
TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM
2007-06-22
TOPCON CORP.
TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA
2004-11-05
TOPCON CORP.