Data / Medical devices / Italy / Elesta SPA
Elesta SPA: FDA-registered device maker in Calenzano Firenze, Italy, 5 510(k) clearances
Elesta SPA is registered with the FDA (registration 3015077548) in Calenzano Firenze, Italy. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 19, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015077548
- Address
- Via Arsiero Salvanti 43, Calenzano Firenze, Italy, 50041
- Owner or operator
- Elesta SPA (10059916)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- June 7, 2019
- Registered through
- 2026
- Brand names listed
- ECHOLASER X4, ESI, INTRODUCER NEEDLE, LASER THERMAL THERAPY KIT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biopsy Needle | FCG | 2 | Exporter to the US | accessdata.fda.gov |
| Instrument, Biopsy | KNW | 2 | Exporter to the US | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Exporter to the US, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| August 19, 2026 | K261964 | ECHOLASER X4 | GEX | Substantially Equivalent | Elesta S.P.A | accessdata.fda.gov |
| March 17, 2026 | K260632 | LASER THERMAL THERAPY KIT | GEX | Substantially Equivalent | Elesta S.P.A | accessdata.fda.gov |
| May 3, 2022 | K213594 | ECHOLASER X4 | GEX | Substantially Equivalent | Elesta S.P.A | accessdata.fda.gov |
| October 15, 2014 | K140470 | OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER | GEX | Substantially Equivalent | Oberon GmbH Fiber Technologies | accessdata.fda.gov |
| July 27, 2005 | K051506 | MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSY | FCG | Substantially Equivalent | Sterylab S.R.L. | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Biopsy
- All makers of Biopsy Needle
- All makers of Medical Device Data System
- All makers of Needle, Aspiration And Injection, Disposable
- All makers of Powered Laser Surgical Instrument
Updated August 19, 2026. 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.