FDA.report

Topcon Healthcare, Inc.

Matched from indexed company URL: Topcon Corporation

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
22428632242863Topcon Healthcare, Inc.1Y2026-01-01111 Bauer Dr Oakland NJ US 07436
30079133393007913399TOPCON EUROPE MEDICAL BV1N2020-04-25Essebaan 11 Capelle a/d IJssel Capelle a/d IJssel Zuid-Holland NL 2908 LJ
30085999943008599994TOPCON MEDICAL LASER SYSTEMS, INC.1N2020-04-25606 Enterprise Ct Livermore CA US 94550
30139864593013986459TOPCON HEALTHCARE SOLUTIONS, INC.1Y2020-04-25111 Bauer Drive Oakland NJ US 07436

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
362811194849754K232555HarmonyNFJ2023-11-20
2114151442875884K182376HarmonyNFJ2018-09-28
362811930111968K182376HarmonyNFJ2018-09-28
362811732363706K171370IMAGEnet 6 Ophthalmic Data SystemNFJ2017-11-01
2114151760725639K171370IMAGEnet 6 Ophthalmic Data SystemNFJ2017-11-01
1210951036029360K170409PASCAL Synthesis Twinstar Ophthalmic Scanning Laser SystemGEX2017-09-12
2114151829271736K151952Synergy ODMNFJ2015-10-01
362812034869577K151952Synergy ODMNFJ2015-10-01
1082801697280410K131567ALADDINHJO2014-06-05
1210951973491672K123542PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASERHQF2013-05-15
1210951867057598K123056PASCAL LASER INDIRECT OPHTHALMOSCOPEHQF2012-11-13
1210951635204245K111108PASCAL STREAMLINE 577 (WITH ACCESSORIES)HQF2011-08-11
1210951148828627K100019PASCAL STREAMLINE PHOTOCOAGULATORHQF2010-05-04
1210951962706677K092621PASCAL STREAMLINE PHOTOCOAGULATORHQF2009-09-25
1210951270596842K091666PASCAL PHOTOCOAGULATOR, PASCAL-USGEX2009-07-15
1210951887788046K081744PASCAL SYNTHESIS DELIVERY SYSTEMGEX2008-09-09
1210952054074796K062336OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPEGEX2006-10-19
1210951429130769K043486PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01GEX2005-03-03
2114151328881090
1210951358570405
1082801488785145
2114151525585314
1082801560310878
1082801629912864
1082801652472699
1082801685313090
1082801810509545
1082801967047729
362811418566269
362811478020805
362811592933023
362811605514848
362811795210075
362811844136882

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
NFJ72023-11-20
GEX52017-09-12
HQF52013-05-15
HJO12014-06-05

PMN

Harmony

2023-11-20

Topcon Healthcare Solutions

Harmony

2018-09-28

Topcon Medical Systems, Inc.

SYNERGY

2009-12-02

TOPCON MEDICAL SYSTEMS, INC.

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GUDID

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