Surgical Green Laser System
K-Number: K202828 · 2021-06-04
Decision Date2021-06-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Surgical Green Laser System is a medical device manufactured by Realton (Suzhou) Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-06-04 under approval number K202828. 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 Surgical Green Laser System?
Surgical Green Laser System is a medical device that received FDA 510(k) clearance on 2021-06-04. It is manufactured by Realton (Suzhou) Medical Technology Co., Ltd.. The 510(k) number is K202828.
When was Surgical Green Laser System approved by the FDA?
Surgical Green Laser System received FDA 510(k) clearance on 2021-06-04, under approval number K202828.
What company makes Surgical Green Laser System?
Surgical Green Laser System is manufactured by Realton (Suzhou) Medical Technology Co., Ltd..
What is the FDA product code for Surgical Green Laser System?
The FDA product code for Surgical Green Laser System is GEX. This falls under the Gastroenterology category.
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Official Source
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