PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01
TOPCON MEDICAL LASER SYSTEMS, INC
Topcon Healthcare, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2242863 | 2242863 | Topcon Healthcare, Inc. | 1 | Y | 2026-01-01 | 111 Bauer Dr Oakland NJ US 07436 |
| 3007913339 | 3007913399 | TOPCON EUROPE MEDICAL BV | 1 | N | 2020-04-25 | Essebaan 11 Capelle a/d IJssel Capelle a/d IJssel Zuid-Holland NL 2908 LJ |
| 3008599994 | 3008599994 | TOPCON MEDICAL LASER SYSTEMS, INC. | 1 | N | 2020-04-25 | 606 Enterprise Ct Livermore CA US 94550 |
| 3013986459 | 3013986459 | TOPCON HEALTHCARE SOLUTIONS, INC. | 1 | Y | 2020-04-25 | 111 Bauer Drive Oakland NJ US 07436 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 36281 | 1194849754 | K232555 | Harmony | NFJ | 2023-11-20 |
| 211415 | 1442875884 | K182376 | Harmony | NFJ | 2018-09-28 |
| 36281 | 1930111968 | K182376 | Harmony | NFJ | 2018-09-28 |
| 36281 | 1732363706 | K171370 | IMAGEnet 6 Ophthalmic Data System | NFJ | 2017-11-01 |
| 211415 | 1760725639 | K171370 | IMAGEnet 6 Ophthalmic Data System | NFJ | 2017-11-01 |
| 121095 | 1036029360 | K170409 | PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System | GEX | 2017-09-12 |
| 211415 | 1829271736 | K151952 | Synergy ODM | NFJ | 2015-10-01 |
| 36281 | 2034869577 | K151952 | Synergy ODM | NFJ | 2015-10-01 |
| 108280 | 1697280410 | K131567 | ALADDIN | HJO | 2014-06-05 |
| 121095 | 1973491672 | K123542 | PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER | HQF | 2013-05-15 |
| 121095 | 1867057598 | K123056 | PASCAL LASER INDIRECT OPHTHALMOSCOPE | HQF | 2012-11-13 |
| 121095 | 1635204245 | K111108 | PASCAL STREAMLINE 577 (WITH ACCESSORIES) | HQF | 2011-08-11 |
| 121095 | 1148828627 | K100019 | PASCAL STREAMLINE PHOTOCOAGULATOR | HQF | 2010-05-04 |
| 121095 | 1962706677 | K092621 | PASCAL STREAMLINE PHOTOCOAGULATOR | HQF | 2009-09-25 |
| 121095 | 1270596842 | K091666 | PASCAL PHOTOCOAGULATOR, PASCAL-US | GEX | 2009-07-15 |
| 121095 | 1887788046 | K081744 | PASCAL SYNTHESIS DELIVERY SYSTEM | GEX | 2008-09-09 |
| 121095 | 2054074796 | K062336 | OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE | GEX | 2006-10-19 |
| 121095 | 1429130769 | K043486 | PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01 | GEX | 2005-03-03 |
| 211415 | 1328881090 | ||||
| 121095 | 1358570405 | ||||
| 108280 | 1488785145 | ||||
| 211415 | 1525585314 | ||||
| 108280 | 1560310878 | ||||
| 108280 | 1629912864 | ||||
| 108280 | 1652472699 | ||||
| 108280 | 1685313090 | ||||
| 108280 | 1810509545 | ||||
| 108280 | 1967047729 | ||||
| 36281 | 1097650632 | ||||
| 36281 | 1155861148 | ||||
| 36281 | 1207282775 | ||||
| 36281 | 1212020275 | ||||
| 36281 | 1314435871 | ||||
| 36281 | 1418566269 | ||||
| 36281 | 1462008560 | ||||
| 36281 | 1478020805 | ||||
| 36281 | 1591922980 | ||||
| 36281 | 1592933023 | ||||
| 36281 | 1605514848 | ||||
| 36281 | 1625486930 | ||||
| 36281 | 1795210075 | ||||
| 36281 | 1844136882 | ||||
| 36281 | 1950024983 |
Product Codes Associated With Registrations#
PMN#
TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA
TOPCON CORP.
TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
TOPCON MEDICAL SYSTEMS, INC.
TOPCON COMPUTERIZED TONOMETER CT-10
TOPCON INSTRUMENT CORPORATION OF AMERICA
GUDID#
SPECULAR MICROSCOPE SP-1P - SP-1P
2016-09-19
MIRROR CHART MC-5S for COMPU VISION CV-5000 - MC-5S
2025-12-09
AUTO KERATO-REFRACTOMETER KR-1 - KR-1
2025-11-21
AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA - TRK-3
2025-11-17
AUTO KERATO-REFRACTOMETER KR-800 - KR-800
2025-10-31
AUTO REFRACTOMETER RM-800 - RM-800
2025-10-31
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2) - 3D OCT-1
2025-09-11
AUTO KERATO-REFRACTOMETER KR-1 - KR-1
2025-06-19
AUTO KERATO-REFRACTOMETER KR-800PA - KR-800PA
2025-05-12
SightPilot NAVi Controller SNi-1 COMPU VISION CV-5000 REFRACTION SYSTEM Chronos - SNi-1
2025-05-01
SightPilot NAVi Controller SNi-1 for COMPU VISION CV-5000 - SNi-1
2025-02-27
AUTO KERATO-REFRACTOMETER KR-800A - KR-800A
2025-04-15
COMPUTERIZED TONOMETER CT-80 - CT-80
2016-09-19
COMPU VISION CV-5000 - CV-5000
2025-02-27
COMPU VISION CV-5000 - CV-5000
2025-02-27
1DIAL CONTROLLER KB-50S - KB-50S
2025-02-27
POWER SUPPLY UNIT for CV-5000 (PC EXTERNAL TYPE) - POWER SUPPLY UNIT for CV-5000
2025-02-27
POWER SUPPLY UNIT for CV-5000 (BUILT-IN PC TYPE) - POWER SUPPLY UNIT for CV-5000
2025-02-27
REFRACTION SYSTEM Chronos - Chronos
2024-08-01
AUTO KERATO-REFRACTOMETER KR-800 - KR-800
2024-05-09
AUTO REFRACTOMETER RM-800 - RM-800
2024-05-09
COMPUTERIZED LENSMETER CL-300 - CL-300
2023-12-19
COMPUTERIZED LENSMETER CL-300 - CL-300
2023-12-19
Chinrest CRX-1000 for REFRACTION SYSTEM Chronos - Chinrest CRX-1000
2023-11-16
INFRARED COMMUNICATION UNIT
2022-08-31
POWER SUPPLY UNIT for CV-5000 (PC EXTERNAL TYPE) - POWER SUPPLY UNIT for CV-5000
2022-08-31
MEASURING HEAD CONNECTION CABLE(14m) for COMPU VISION CV-5000 - MEASURING HEAD CONNECTION CABLE(14m) for COMPU VIS
2022-08-31
POWER SUPPLY UNIT for CV-5000 (BUILT-IN PC TYPE) - POWER SUPPLY UNIT for CV-5000
2022-08-31
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000 - 3D OCT-2000
2016-09-19
IMAGEnet 6 OPHTHALMIC DATA SYSTEM - IMAGEnet 6
2018-02-07
TL-5A
2022-08-31
OBLIQUE ILLUMINATOR MS-OI04 - MS-OI04
2022-08-31
BEAM SPLITTER MS-BS03-50/50 - MS-BS03-50/50
2022-08-31
TV RELAY LENS TL-6A - TL-6A
2022-08-31
TV RELAY LENS TL-7A - TL-7A
2022-08-31
TV RELAY LENS TL-7A - TL-7A
2022-08-31
TV RELAY LENS TL-6A - TL-6A
2022-08-31
FIXATION TARGET
2021-02-03
OBSERVATION TUBE + BEAM SPLITTER
2021-02-03
OBSERVATION TUBE
2021-02-03