Medical Diode Laser (Model: L2)
K-Number: K240179 · 2024-03-21
ApplicantWuhan Pioon Technology Co., Ltd.
Decision Date2024-03-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Medical Diode Laser (Model: L2) is a medical device manufactured by Wuhan Pioon Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-03-21 under approval number K240179. 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 Medical Diode Laser (Model: L2)?
Medical Diode Laser (Model: L2) is a medical device that received FDA 510(k) clearance on 2024-03-21. It is manufactured by Wuhan Pioon Technology Co., Ltd.. The 510(k) number is K240179.
When was Medical Diode Laser (Model: L2) approved by the FDA?
Medical Diode Laser (Model: L2) received FDA 510(k) clearance on 2024-03-21, under approval number K240179.
What company makes Medical Diode Laser (Model: L2)?
Medical Diode Laser (Model: L2) is manufactured by Wuhan Pioon Technology Co., Ltd..
What is the FDA product code for Medical Diode Laser (Model: L2)?
The FDA product code for Medical Diode Laser (Model: L2) 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.