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Data / Medical devices / Italy / Emoled SRL

Emoled SRL: FDA-registered device maker in Sesto Fiorentino Firenze, Italy, 1 510(k) clearance

Emoled SRL is registered with the FDA (registration 3025861981) in Sesto Fiorentino Firenze, Italy. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 12, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3025861981
Address
Via di rimaggio 141 int. 25, Sesto Fiorentino Firenze, Italy, 50019
Owner or operator
Emoled srl (10095932)
Roles
Manufacturer
First device listed
May 26, 2026
Registered through
2026
Brand names listed
EmoLED V2-USA

Devices it lists

DeviceProduct codeClassRoleSource
Powered Laser Surgical InstrumentGEX2Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 12, 2024K240132EmoLED (v. 2-USA)GEXSubstantially EquivalentEmoled, Srlaccessdata.fda.gov

Compare with other makers

Updated March 12, 2024. 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.