Medical Device Manufacturer · IT , Lecce

Echolight S.P.A - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2018

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Echolight S.P.A Radiology ✕

3 devices

1-3 of 3

Cleared Mar 16, 2022

EchoSK and EchoSGyn modules for EchoS Family devices

Radiology · 190d

Cleared Feb 25, 2021

Radiology · 178d

Cleared Oct 19, 2018

Radiology · 234d

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 20, 2026