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FDA 510(k)

Venus Versa System

K-Number: K153717 · 2016-03-21

ApplicantVenus Concept , Ltd.
Decision Date2016-03-21
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Venus Versa System is a medical device manufactured by Venus Concept , Ltd.. It received FDA 510(k) clearance on 2016-03-21 under approval number K153717. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Venus Versa System?

Venus Versa System is a medical device that received FDA 510(k) clearance on 2016-03-21. It is manufactured by Venus Concept , Ltd.. The 510(k) number is K153717.

When was Venus Versa System approved by the FDA?

Venus Versa System received FDA 510(k) clearance on 2016-03-21, under approval number K153717.

What company makes Venus Versa System?

Venus Versa System is manufactured by Venus Concept , Ltd..

What is the FDA product code for Venus Versa System?

The FDA product code for Venus Versa System is ONF.

Other Devices by Venus Concept , Ltd.

K152790Venus Versa System K162765Venus Velocity Diode Laser System

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K161565DUOStetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd K161286IPL Therapy MachineBeijing Adss Development Co., Ltd. K160195Forma System, Forma Light SystemFormatk Systems , Ltd. K152790Venus Versa SystemVenus Concept , Ltd. K181868SHINY RPL SystemIds, Ltd. K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.

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.

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