Data / Medical devices / Italy / Eltech K-Laser S.R.L.
Eltech K-Laser S.R.L.: FDA-registered device maker in Treviso, Italy, 1 510(k) clearance
Eltech K-Laser S.R.L. is registered with the FDA (registration 3004642415) in Treviso, Italy. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 25, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004642415
- Address
- Via Castagnole, 20/H-Interno 2, Treviso, Italy, 31100
- Owner or operator
- ELTECH K-LASER, S.R.L. (9067781)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- September 24, 2012
- Registered through
- 2026
- Brand names listed
- GIRO CORE, GIRO ELITE, GIRO ULTRA, K-Laser Cube Plus 30, K-laser Cube1, K-laser Cube2, K-laser Cube 3, K-laser Cube 4, Speciale Live Therapy, Speciale Live Therapy Plus
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| May 25, 2012 | K120604 | K-LASER | ILY | Substantially Equivalent | Eltech S.R.L | accessdata.fda.gov |
Compare with other makers
Updated May 25, 2012. 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.