Q-Switched Nd: YAG Laser System
K-Number: K190936 · 2019-06-17
Decision Date2019-06-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Q-Switched Nd: YAG Laser System is a medical device manufactured by Shanghai Apolo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-06-17 under approval number K190936. 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 Q-Switched Nd: YAG Laser System?
Q-Switched Nd: YAG Laser System is a medical device that received FDA 510(k) clearance on 2019-06-17. It is manufactured by Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K190936.
When was Q-Switched Nd: YAG Laser System approved by the FDA?
Q-Switched Nd: YAG Laser System received FDA 510(k) clearance on 2019-06-17, under approval number K190936.
What company makes Q-Switched Nd: YAG Laser System?
Q-Switched Nd: YAG Laser System is manufactured by Shanghai Apolo Medical Technology Co., Ltd..
What is the FDA product code for Q-Switched Nd: YAG Laser System?
The FDA product code for Q-Switched 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.