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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 the device name listed in this FDA 510(k) record. The listed applicant is Ilooda Co,., Ltd.. It received FDA 510(k) clearance on 2023-09-15 under 510(k) 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. The listed applicant is Ilooda Co,., Ltd.. The 510(k) number is K231791.

When did PENTO Nd:YAG and Alexandrite laser system receive FDA 510(k) clearance?

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

Who is the listed applicant for PENTO Nd:YAG and Alexandrite laser system?

The FDA 510(k) record lists Ilooda Co,., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

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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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