# Topcon Healthcare Solutions EMEA Oy

- Location (FDA's records): Oulu, FI
- FDA decisions: 2 (2021–2026): 2 510(k) clearances
- Product codes: NFJ (2)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Topcon Medical Systems, Inc.: 1 (https://510kreport.com/company/topcon-medical-systems)
- Topcon Corporation: 1 (https://510kreport.com/company/topcon)

## Its most-cited devices
- K210396: Harmony Referral System (2021), cited by 1

## Recent decisions
- K253893: Harmony Referral System with Harmony OCT Viewer (Octave) (Jun 4, 2026)
- K210396: Harmony Referral System (Sep 13, 2021)

Source page: https://510kreport.com/company/topcon-healthcare-solutions-emea