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 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 36281 | 1194849754 | K232555 | Harmony | NFJ | 2023-11-20 |
| 36281 | 1930111968 | K182376 | Harmony | NFJ | 2018-09-28 |
| 36281 | 1732363706 | K171370 | IMAGEnet 6 Ophthalmic Data System | NFJ | 2017-11-01 |
| 36281 | 2034869577 | K151952 | Synergy ODM | NFJ | 2015-10-01 |
| 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#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| NFJ | 4 | 2023-11-20 |