Phototherapy System
K-Number: K190938 · 2019-06-26
Decision Date2019-06-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Phototherapy System is a medical device manufactured by Shanghai Apolo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-06-26 under approval number K190938. 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 Phototherapy System?
Phototherapy System is a medical device that received FDA 510(k) clearance on 2019-06-26. It is manufactured by Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K190938.
When was Phototherapy System approved by the FDA?
Phototherapy System received FDA 510(k) clearance on 2019-06-26, under approval number K190938.
What company makes Phototherapy System?
Phototherapy System is manufactured by Shanghai Apolo Medical Technology Co., Ltd..
What is the FDA product code for Phototherapy System?
The FDA product code for Phototherapy System is GEX. This falls under the Gastroenterology category.
Other Devices by Shanghai Apolo Medical Technology Co., Ltd.
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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.