Harmony Referral System with Harmony OCT Viewer (Octave)
FDA 510(k) K253893 · Topcon Healthcare Solutions EMEA Oy
510(k) numberK253893
Submission
- Device name
- Harmony Referral System with Harmony OCT Viewer (Octave)
- Applicant
- Topcon Healthcare Solutions EMEA Oy
Oulu, FI - Received
- December 4, 2025
- Decision date
- June 4, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K220929 | ExcelsiorNFJ · Traditional | Merit Cro, Inc. | 10/31/2022SE |
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More from Retinai Medical AG
| 510(k) | Device | Decision |
|---|---|---|
| K210396 | Harmony Referral SystemNFJ · Traditional | 09/13/2021SE |
Questions and answers
When was Harmony Referral System with Harmony OCT Viewer (Octave) cleared by the FDA?
Harmony Referral System with Harmony OCT Viewer (Octave) (K253893) received a 510(k) decision of Substantially Equivalent on June 4, 2026, 182 days after the submission was received.
What is the product code of K253893?
The FDA product code is NFJ – System, Image Management, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 892.2050.