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FDA 510(k)

Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT

K-Number: K241092 · 2024-10-10

ApplicantQuanta System Spa
Decision Date2024-10-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT is a medical device manufactured by Quanta System Spa. It received FDA 510(k) clearance on 2024-10-10 under approval number K241092. 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 PRIME; Youlaser PRIME CO2; Youlaser PRIME MT?

Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT is a medical device that received FDA 510(k) clearance on 2024-10-10. It is manufactured by Quanta System Spa. The 510(k) number is K241092.

When was Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT approved by the FDA?

Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT received FDA 510(k) clearance on 2024-10-10, under approval number K241092.

What company makes Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT?

Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT is manufactured by Quanta System Spa.

What is the FDA product code for Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT?

The FDA product code for Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT is GEX. This falls under the Gastroenterology category.

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Official Source

View on FDA Database →

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

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