Medical Device Manufacturer · KR , Seoul

Lunit, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2021

Total

Cleared

Denied

Lunit, Inc. has 6 FDA 510(k) cleared medical devices. Based in Seoul, KR.

Latest FDA clearance: Apr 2026. Active since 2021. Primary specialty: Radiology.

Browse the FDA 510(k) cleared devices submitted by Lunit, Inc. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Hogan Lovells US LLP and Hogan Lovells.

Lunit, Inc. is one of 351 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Lunit, Inc.

6 devices

1-6 of 6

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: May 06, 2026