FDA 510(k)

Solon

K-Number: K221766 · 2024-01-05

ApplicantLmg Lasers Comercio, Importacao E Exportacao Ltda

Decision Date2024-01-05

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Solon is a medical device manufactured by Lmg Lasers Comercio, Importacao E Exportacao Ltda. It received FDA 510(k) clearance on 2024-01-05 under approval 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.

Frequently Asked Questions

What is the Solon?

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

When was Solon approved by the FDA?

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

What company makes Solon?

Solon is manufactured by Lmg Lasers Comercio, Importacao E Exportacao Ltda.

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.