Topcon Healthcare Solutions EMEA Oy
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 2
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253893 | Harmony Referral System with Harmony OCT Viewer (Octave) | June 4, 2026 |
| K210396 | Harmony Referral System | September 13, 2021 |