FDA 510(k)

LASEmaR 1500

Número K: K260489 · 2026-05-29

Data da decisão2026-05-29

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

LASEmaR 1500 is the device name listed in this FDA 510(k) record. The listed applicant is Eufoton S.R.L.. It received FDA 510(k) clearance on 2026-05-29 under 510(k) number K260489. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LASEmaR 1500?

LASEmaR 1500 is a medical device that received FDA 510(k) clearance on 2026-05-29. The listed applicant is Eufoton S.R.L.. The 510(k) number is K260489.

When did LASEmaR 1500 receive FDA 510(k) clearance?

LASEmaR 1500 received FDA 510(k) clearance on 2026-05-29, under 510(k) number K260489.

Who is the listed applicant for LASEmaR 1500?

The FDA 510(k) record lists Eufoton S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LASEmaR 1500?

The FDA product code for LASEmaR 1500 is GEX. This falls under the Gastroenterology category.

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