Data / Medical devices / Italy / Echolight S.P.A.
Echolight S.P.A.: FDA-registered device maker in Lecce, Italy, 3 510(k) clearances
Echolight S.P.A. is registered with the FDA (registration 3015973732) in Lecce, Italy. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 16, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015973732
- Address
- Viale Cipro 6, Lecce, Italy, 73100
- Owner or operator
- ECHOLIGHT S.P.A. (10061416)
- Roles
- Manufacturer
- First device listed
- October 16, 2019
- Registered through
- 2026
- Brand names listed
- EchoS, EchoSGyn, EchoSK, EchoStation, EchoStudio, OsteoS, OsteoStation, OsteoStudio
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bone Sonometer | MUA | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| Ultrasonic Body Composition Analyzer | OMV | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 16, 2022 | K212851 | EchoSK and EchoSGyn modules for EchoS Family devices | IYO | Substantially Equivalent | Echolight S.P.A | accessdata.fda.gov |
| February 25, 2021 | K202514 | EchoS Family | MUA | Substantially Equivalent | Echolight S.P.A | accessdata.fda.gov |
| October 19, 2018 | K180516 | EchoS | MUA | Substantially Equivalent | Echolight S.P.A | accessdata.fda.gov |
Compare with other makers
Updated March 16, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.