810nm Diode Laser System
K-Number: K183122 · 2019-08-25
Decision Date2019-08-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
810nm Diode Laser System is a medical device manufactured by Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. It received FDA 510(k) clearance on 2019-08-25 under approval number K183122. 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 810nm Diode Laser System?
810nm Diode Laser System is a medical device that received FDA 510(k) clearance on 2019-08-25. It is manufactured by Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. The 510(k) number is K183122.
When was 810nm Diode Laser System approved by the FDA?
810nm Diode Laser System received FDA 510(k) clearance on 2019-08-25, under approval number K183122.
What company makes 810nm Diode Laser System?
810nm Diode Laser System is manufactured by Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd.
What is the FDA product code for 810nm Diode Laser System?
The FDA product code for 810nm Diode 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.