Data / Medical devices / Italy / Led SPA
Led SPA: FDA-registered device maker in Aprilia Latina, Italy, 1 510(k) clearance
Led SPA is registered with the FDA (registration 3006411077) in Aprilia Latina, Italy. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 5, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006411077
- Address
- via Selciatella, 40, Aprilia Latina, Italy, 04011
- Owner or operator
- LED SPA (10086740)
- Roles
- Manufacturer
- First device listed
- December 7, 2022
- Registered through
- 2027
- Brand names listed
- SURTRON
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 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 |
|---|---|---|---|---|---|---|
| October 5, 2022 | K220138 | Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP | GEI | Substantially Equivalent | Led Spa | accessdata.fda.gov |
Compare with other makers
Updated October 5, 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.