Diode laser therapy system
K-Number: K212978 · 2021-11-10
ApplicantBeijing Unt Technology Co., Ltd.
Decision Date2021-11-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Diode laser therapy system is a medical device manufactured by Beijing Unt Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-10 under approval number K212978. 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 system?
Diode laser therapy system is a medical device that received FDA 510(k) clearance on 2021-11-10. It is manufactured by Beijing Unt Technology Co., Ltd.. The 510(k) number is K212978.
When was Diode laser therapy system approved by the FDA?
Diode laser therapy system received FDA 510(k) clearance on 2021-11-10, under approval number K212978.
What company makes Diode laser therapy system?
Diode laser therapy system is manufactured by Beijing Unt Technology Co., Ltd..
What is the FDA product code for Diode laser therapy system?
The FDA product code for Diode laser therapy 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.