reepot Nd; YAG laser system
K-Number: K222555 · 2022-09-23
ApplicantIlooda Co,., Ltd.
Decision Date2022-09-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
reepot Nd; YAG laser system is a medical device manufactured by Ilooda Co,., Ltd.. It received FDA 510(k) clearance on 2022-09-23 under approval number K222555. 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 reepot Nd; YAG laser system?
reepot Nd; YAG laser system is a medical device that received FDA 510(k) clearance on 2022-09-23. It is manufactured by Ilooda Co,., Ltd.. The 510(k) number is K222555.
When was reepot Nd; YAG laser system approved by the FDA?
reepot Nd; YAG laser system received FDA 510(k) clearance on 2022-09-23, under approval number K222555.
What company makes reepot Nd; YAG laser system?
reepot Nd; YAG laser system is manufactured by Ilooda Co,., Ltd..
What is the FDA product code for reepot Nd; YAG laser system?
The FDA product code for reepot Nd; YAG laser system 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.