Medical Device Manufacturer · FI , Oulu

Optomed OY - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2009

Total

Cleared

Denied

Optomed OY has 5 FDA 510(k) cleared medical devices. Based in Oulu, FI.

Historical record: 5 cleared submissions from 2009 to 2018. Primary specialty: Ophthalmic.

Browse the FDA 510(k) cleared devices submitted by Optomed OY Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Underwriters Laboratories, Inc. as regulatory consultant.

Optomed OY is one of 50 FDA 510(k) medical device manufacturers from Finland in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Optomed OY

5 devices

1-5 of 5

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Jun 08, 2026