Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Topcon Healthcare Solutions EMEA Oy

FDA 510(k) & PMA Approved Devices — 2 products

Total Devices2
Categories1
Latest FDA decision2026-06-04
TypeNumberDevice NameCodeDateActions
510(k) K253893 Harmony Referral System with Harmony OCT Viewer (Octave)NFJ2026-06-04 View
510(k) K210396 Harmony Referral SystemNFJ2021-09-13 View