PicoSecond Nd: YAG Laser System
K-Number: K200116 · 2020-05-28
Decision Date2020-05-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
PicoSecond Nd: YAG Laser System is a medical device manufactured by Shanghai Apolo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-05-28 under approval number K200116. 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 2020-05-28. It is manufactured by Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K200116.
When was PicoSecond Nd: YAG Laser System approved by the FDA?
PicoSecond Nd: YAG Laser System received FDA 510(k) clearance on 2020-05-28, under approval number K200116.
What company makes PicoSecond Nd: YAG Laser System?
PicoSecond Nd: YAG Laser System is manufactured by Shanghai Apolo 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.