Picosecond Nd:YAG Laser System
K-Number: K240118 · 2024-04-30
Decision Date2024-04-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Picosecond Nd:YAG Laser System is a medical device manufactured by Smedtrum Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-04-30 under approval number K240118. 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 Picosecond Nd:YAG Laser System?
Picosecond Nd:YAG Laser System is a medical device that received FDA 510(k) clearance on 2024-04-30. It is manufactured by Smedtrum Medical Technology Co., Ltd.. The 510(k) number is K240118.
When was Picosecond Nd:YAG Laser System approved by the FDA?
Picosecond Nd:YAG Laser System received FDA 510(k) clearance on 2024-04-30, under approval number K240118.
What company makes Picosecond Nd:YAG Laser System?
Picosecond Nd:YAG Laser System is manufactured by Smedtrum Medical Technology Co., Ltd..
What is the FDA product code for Picosecond Nd:YAG Laser System?
The FDA product code for Picosecond 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.