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FDA 510(k)

PENTO Nd:YAG and Alexandrite laser system

K-Number: K231791 · 2023-09-15

ApplicantIlooda Co,., Ltd.
Decision Date2023-09-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PENTO Nd:YAG and Alexandrite laser system is a medical device manufactured by Ilooda Co,., Ltd.. It received FDA 510(k) clearance on 2023-09-15 under approval number K231791. 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 PENTO Nd:YAG and Alexandrite laser system?

PENTO Nd:YAG and Alexandrite laser system is a medical device that received FDA 510(k) clearance on 2023-09-15. It is manufactured by Ilooda Co,., Ltd.. The 510(k) number is K231791.

When was PENTO Nd:YAG and Alexandrite laser system approved by the FDA?

PENTO Nd:YAG and Alexandrite laser system received FDA 510(k) clearance on 2023-09-15, under approval number K231791.

What company makes PENTO Nd:YAG and Alexandrite laser system?

PENTO Nd:YAG and Alexandrite laser system is manufactured by Ilooda Co,., Ltd..

What is the FDA product code for PENTO Nd:YAG and Alexandrite laser system?

The FDA product code for PENTO Nd:YAG and Alexandrite laser system is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

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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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