Venus Velocity Diode Laser System
K-Number: K162765 · 2017-01-11
ApplicantVenus Concept , Ltd.
Decision Date2017-01-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Venus Velocity Diode Laser System is a medical device manufactured by Venus Concept , Ltd.. It received FDA 510(k) clearance on 2017-01-11 under approval number K162765. 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 Velocity Diode Laser System?
Venus Velocity Diode Laser System is a medical device that received FDA 510(k) clearance on 2017-01-11. It is manufactured by Venus Concept , Ltd.. The 510(k) number is K162765.
When was Venus Velocity Diode Laser System approved by the FDA?
Venus Velocity Diode Laser System received FDA 510(k) clearance on 2017-01-11, under approval number K162765.
What company makes Venus Velocity Diode Laser System?
Venus Velocity Diode Laser System is manufactured by Venus Concept , Ltd..
What is the FDA product code for Venus Velocity Diode Laser System?
The FDA product code for Venus Velocity Diode Laser 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.