Diode Laser Therapy Device
K-Number: K200118 · 2020-04-17
Decision Date2020-04-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Diode Laser Therapy Device is a medical device manufactured by Shanghai Apolo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-04-17 under approval number K200118. 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 Device?
Diode Laser Therapy Device is a medical device that received FDA 510(k) clearance on 2020-04-17. It is manufactured by Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K200118.
When was Diode Laser Therapy Device approved by the FDA?
Diode Laser Therapy Device received FDA 510(k) clearance on 2020-04-17, under approval number K200118.
What company makes Diode Laser Therapy Device?
Diode Laser Therapy Device is manufactured by Shanghai Apolo Medical Technology Co., Ltd..
What is the FDA product code for Diode Laser Therapy Device?
The FDA product code for Diode Laser Therapy Device 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.