Venus Epileve
K-Number: K200786 · 2020-06-09
ApplicantVenus Concept USA, Inc.
Decision Date2020-06-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Venus Epileve is a medical device manufactured by Venus Concept USA, Inc.. It received FDA 510(k) clearance on 2020-06-09 under approval number K200786. 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 Venus Epileve?
Venus Epileve is a medical device that received FDA 510(k) clearance on 2020-06-09. It is manufactured by Venus Concept USA, Inc.. The 510(k) number is K200786.
When was Venus Epileve approved by the FDA?
Venus Epileve received FDA 510(k) clearance on 2020-06-09, under approval number K200786.
What company makes Venus Epileve?
Venus Epileve is manufactured by Venus Concept USA, Inc..
What is the FDA product code for Venus Epileve?
The FDA product code for Venus Epileve is GEX. This falls under the Gastroenterology category.
Other Devices by Venus Concept USA, Inc.
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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.