Harmony 6.0
Harmony 6.0 is a Class II device made by Topcon Healthcare, Inc., cleared under FDA 510(k) K232555 on 20 Nov 2023 and listed in FDA GUDID since 4 Mar 2025 (UDI-DI 00850003069531), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850003069531 | Date4 Mar 2025 | StatusListed |
| United States | FDA 510(k) | NumberK232555 | Date20 Nov 2023 | StatusActive |
Official records
- AccessGUDID record 00850003069531
- FDA 510(k) database K232555
Across registries
- FDA 510(k) K232555 decided 20 Nov 2023 Active
- FDA GUDID UDI-DI 00850003069531 listed 4 Mar 2025 Listed
Timeline
- Cleared FDA 510(k) K232555
- Listed FDA GUDID 00850003069531
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Harmony
- Generic name
- Camera application software
- Model / reference
- 6.0
- Primary DI / UDI-DI
- 00850003069531
- 510(k) Number
- FDA product code
- NFJ
- GMDN term
- Camera application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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