Harmony Referral System with Harmony OCT Viewer (Octave)
Summary
Topcon Healthcare Solutions EMEA Oy received 510(k) clearance for Harmony Referral System with Harmony OCT Viewer (Octave), a NFJ device. Cleared on 2026-06-04.
Details
Source
510(k) Clearance
External ID
K253893
Action Date
2026-06-04
Status
Traditional
Category
device
Product Code
NFJ
Product Description
Harmony Referral System with Harmony OCT Viewer (Octave). Product code: NFJ.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Topcon Healthcare Solutions EMEA Oy has received 2 total clearances in our database.
Topcon Healthcare Solutions EMEA Oy has 2 FDA actions in our database, including 2 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Topcon Healthcare Solutions EMEA Oy have FDA actions?
Topcon Healthcare Solutions EMEA Oy has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K253893" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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