Diode Laser Therapy Systems
K-Number: K210168 · 2021-05-10
Decision Date2021-05-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Diode Laser Therapy Systems is a medical device manufactured by Beijing Kes Biology Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-05-10 under approval number K210168. 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 Diode Laser Therapy Systems?
Diode Laser Therapy Systems is a medical device that received FDA 510(k) clearance on 2021-05-10. It is manufactured by Beijing Kes Biology Technology Co., Ltd.. The 510(k) number is K210168.
When was Diode Laser Therapy Systems approved by the FDA?
Diode Laser Therapy Systems received FDA 510(k) clearance on 2021-05-10, under approval number K210168.
What company makes Diode Laser Therapy Systems?
Diode Laser Therapy Systems is manufactured by Beijing Kes Biology Technology Co., Ltd..
What is the FDA product code for Diode Laser Therapy Systems?
The FDA product code for Diode Laser Therapy Systems 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.