FDA 510(k)

Youlaser CO2

K-Number: K182669 · 2018-10-17

Decision Date2018-10-17

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Youlaser CO2 is a medical device manufactured by Quanta System Spa. It received FDA 510(k) clearance on 2018-10-17 under approval number K182669. 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 Youlaser CO2?

Youlaser CO2 is a medical device that received FDA 510(k) clearance on 2018-10-17. It is manufactured by Quanta System Spa. The 510(k) number is K182669.

When was Youlaser CO2 approved by the FDA?

Youlaser CO2 received FDA 510(k) clearance on 2018-10-17, under approval number K182669.

What company makes Youlaser CO2?

Youlaser CO2 is manufactured by Quanta System Spa.

What is the FDA product code for Youlaser CO2?

The FDA product code for Youlaser CO2 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.