Echolight S.P.A
ItalyFDA 510(k) applicant, unverified FDA
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Echolight S.P.A makes
Echolight S.P.A. manufactures ultrasound imaging systems, including the EchoS platform and its modular components like EchoSK and EchoSGyn for specialized applications. These devices are designed for diagnostic imaging in medical settings, supporting real-time visualization of internal structures.
The company’s products fall under FDA Class II devices and are listed via the 510(k) pathway. The portfolio is regulated under U.S. medical device laws, with devices authorized for commercial distribution in the United States.
Catalogue
EchoS Ref K180516
510(k) 510(k)- 510(k) 510(k)
EchoS Family Ref K202514
510(k) 510(k)
FDA establishments
- Echolight S.P.A. Lecce · IT FEI 3015973732
Frequently asked questions
How many devices does Echolight S.P.A have in the registry?
The registry currently lists 3 devices for Echolight S.P.A. Devices recorded under merged duplicate company entries are counted once.
Which registries list Echolight S.P.A's devices?
Among its 3 most recently registered devices, Echolight S.P.A has devices listed in FDA 510(k) (3 devices).
What risk classes do Echolight S.P.A's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Echolight S.P.A's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Echolight S.P.A in the registry?
The most recently registered devices listed for Echolight S.P.A include EchoS, EchoSK and EchoSGyn modules for EchoS Family devices and EchoS Family.
Which FDA establishments are linked to Echolight S.P.A?
1 FDA establishment is linked to Echolight S.P.A in the registry; they are listed on the company page.