Data / Medical devices / Powered Laser Surgical Instrument / Italy
FDA-registered makers of Powered Laser Surgical Instrument in Italy: 17 establishments
17 establishments in Italy are registered with the FDA to make Powered Laser Surgical Instrument (product code GEX). 15 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- Powered Laser Surgical Instrument
- Product code
- GEX
- Country
- Italy
Makers of Powered Laser Surgical Instrument in Italy
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Quanta System, S.P.A. | SAMARATE Varese, Italy | Contract manufacturer, Exporter to the US, Manufacturer | 34 | June 6, 2025 | 0 | 2 | 0 | api.fda.gov |
| El.en. Electronic Engineering SPA | CALENZANO Firenze, Italy | Contract manufacturer, Exporter to the US, Manufacturer | 33 | August 19, 2026 | 0 | 0 | 0 | api.fda.gov |
| Elesta SPA | Calenzano Firenze, Italy | Exporter to the US, Manufacturer, Specification developer | 4 | August 19, 2026 | 0 | 0 | 0 | api.fda.gov |
| Bios S.R.L. | VIMODRONE Milano, Italy | Exporter to the US, Manufacturer | 3 | December 30, 2024 | 0 | 0 | 0 | api.fda.gov |
| M&T SRL | rimini, Italy | Manufacturer | 3 | September 20, 2024 | 0 | 0 | 0 | api.fda.gov |
| Espansione Marketing SPA | FUNO Bologna, Italy | Manufacturer | 2 | September 20, 2010 | 0 | 0 | 0 | api.fda.gov |
| Espansione Marketing SPA | CREVALCORE Bologna, Italy | Manufacturer | 2 | September 20, 2010 | 0 | 0 | 0 | api.fda.gov |
| Lambda SPA | Brendola Vicenza, Italy | Manufacturer | 2 | September 28, 2010 | 0 | 0 | 0 | api.fda.gov |
| Lasering S.R.L. | MODENA Emilia-Romagna, Italy | Exporter to the US, Manufacturer | 2 | March 7, 2007 | 0 | 0 | 0 | api.fda.gov |
| Biotec SRL | Dueville Vicenza, Italy | Manufacturer | 1 | August 15, 2022 | 0 | 0 | 0 | api.fda.gov |
| D.E.A. Project S.R.L. | Mapello Bergamo, Italy | Manufacturer | 1 | April 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Emoled SRL | Sesto Fiorentino Firenze, Italy | Manufacturer | 1 | March 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Eufoton S.R.L. | Trieste, Italy | Manufacturer | 1 | July 16, 2010 | 0 | 0 | 0 | api.fda.gov |
| Hyper Photonics S.R.L. | Concorezzo Monza e Brianza, Italy | Manufacturer | 1 | June 23, 2017 | 0 | 0 | 0 | api.fda.gov |
| Medency SRL | Vicenza Veneto, Italy | Complaint file establishment, Manufacturer, Specification developer | 1 | October 24, 2024 | 0 | 0 | 0 | api.fda.gov |
| Eltech K-Laser S.R.L. | Treviso, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STERIL VERONA s.r.l. | ERBE Verona, Italy | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.