FDA 510(k)

Solon

Número K: K221766 · 2024-01-05

RequerenteLmg Lasers Comercio, Importacao E Exportacao Ltda

Data da decisão2024-01-05

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Solon is the device name listed in this FDA 510(k) record. The listed applicant is Lmg Lasers Comercio, Importacao E Exportacao Ltda. It received FDA 510(k) clearance on 2024-01-05 under 510(k) number K221766. 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 Solon?

Solon is a medical device that received FDA 510(k) clearance on 2024-01-05. The listed applicant is Lmg Lasers Comercio, Importacao E Exportacao Ltda. The 510(k) number is K221766.

When did Solon receive FDA 510(k) clearance?

Solon received FDA 510(k) clearance on 2024-01-05, under 510(k) number K221766.

Who is the listed applicant for Solon?

The FDA 510(k) record lists Lmg Lasers Comercio, Importacao E Exportacao Ltda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Solon?

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

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