510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Topcon Corp.

Tokyo, JP

TOPCON CORP. appears in FDA device records in Tokyo, JP. FDA records list 22 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
22
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 22 510(k) clearances for Topcon Corp. between 2004 and 2025. The busiest year on record is 2014, with 3. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Topcon Corp., by decision year
YearClearances
20041
20071
20081
20092
20101
20131
20143
20151
20162
20172
20181
20221
20231
20243
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253039AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIAHKXSubstantially Equivalent
K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data SystemOBOSubstantially Equivalent
K2335613D Optical Coherence Tomography (3D OCT-1(type: Maestro2))OBOSubstantially Equivalent
K232828IMAGEnet6 Ophthalmic Data SystemNFJSubstantially Equivalent
K2312223D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)OBOSubstantially Equivalent
K221111Non-Mydriatic Retinal Camera NW500HKISubstantially Equivalent
K173119DRI OCT TritonOBOSubstantially Equivalent
K171370IMAGEnet 6 Ophthalmic Data SystemNFJSubstantially Equivalent
K1701643D OCT-1 MaestroOBOSubstantially Equivalent
K161972Slit Lamp SL-D301HJOSubstantially Equivalent
K1615093D OCT-1 MaestroOBOSubstantially Equivalent
K142417SP-1PSpecular MicroscopeNQESubstantially Equivalent
K141325TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERAHKISubstantially Equivalent
K141481TRC-NW400 NON-MYDRIATIC RETINAL CAMERAHKISubstantially Equivalent
K133667SLIT LAMP SL-D701HJOSubstantially Equivalent
K130289TRC-NW8 NON-MYDRIATIC RETINAL CAMERAHKISubstantially Equivalent
K100207NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8FHKISubstantially Equivalent
K092470OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000OBOSubstantially Equivalent
K090115RETINA CAMERA TRC-NW7SF MARK IIHKISubstantially Equivalent
K082364IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FORNFJSubstantially Equivalent
K063388TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEMOBOSubstantially Equivalent
K041367TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERAHKISubstantially Equivalent

Registered establishments

FDA registered establishments for Topcon Corp., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96146611000175127TOPCON CORP.75-1 HASUNUMA-CHO, TOKYO 174-8580 JP2026and 9 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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Data as of , FDA export datePage updated Source: openFDA, public domain