FDA Registration
Active
🇺🇸 United States
Topcon Healthcare, Inc.
Reg #: 2242863
·
FEI: 2242863
·
Expires 2026
Products
9
Proprietary Names
13
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- Topcon Healthcare, Inc.
- Registration Number
- 2242863
- FEI Number
- 2242863
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 111 Bauer Dr
- City
- Oakland
- State
- NJ
- ZIP
- 07436
- Country
- US
Regulatory Submissions
- 510(k) Number
- K182376
Owner / Operator
- Firm Name
- Topcon Healthcare, Inc.
- Operator Number
- 2242863
- Address
- 111 Bauer Drive
- City
- Oakland
- State
- NJ
- Postal Code
- 07436
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Management, Ophthalmic | NFJ | Class 2 | Radiology | No | 2018-10-10 |
| Table, Instrument, Powered, Ophthalmic | HRJ | Class 1 | Ophthalmic | No | 1994-12-13 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2014-10-27 |
| Chair, Ophthalmic, Manual | HMD | Class 1 | Ophthalmic | No | 2008-01-14 |
| Stand, Instrument, Ac-Powered, Ophthalmic | HMF | Class 1 | Ophthalmic | No | 1994-12-13 |
| Projector, Ophthalmic | HOS | Class 1 | Ophthalmic | No | 2008-12-30 |
| Tomography, Optical Coherence | OBO | Class 2 | Ophthalmic | No | 2024-06-18 |
| Camera, Ophthalmic, Ac-Powered | HKI | Class 2 | Ophthalmic | No | 2024-06-18 |
| Chair, Ophthalmic, Ac-Powered | HME | Class 1 | Ophthalmic | No | 1994-12-13 |
Proprietary Names
Harmony
Synergy ODM
AIT-250W; AIT-350W; AIT-650; IDS-300; AIT-W1; AIT-W2
CLOUD
EZ Lite 2
OS-100; OS-200
OS-300; OS-400
IS-5000; CS-5; IS-5500
IS-6500
VisiChart II
VisiChart
OC-2200
OC-2300; OC-2400
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility