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FDA 510(k)

Viveve System

K-Number: K162547 · 2016-10-06

ApplicantViveve, Inc.
Decision Date2016-10-06
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Viveve System is a medical device manufactured by Viveve, Inc.. It received FDA 510(k) clearance on 2016-10-06 under approval number K162547. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Viveve System?

Viveve System is a medical device that received FDA 510(k) clearance on 2016-10-06. It is manufactured by Viveve, Inc.. The 510(k) number is K162547.

When was Viveve System approved by the FDA?

Viveve System received FDA 510(k) clearance on 2016-10-06, under approval number K162547.

What company makes Viveve System?

Viveve System is manufactured by Viveve, Inc..

What is the FDA product code for Viveve System?

The FDA product code for Viveve System is GEI.

Other Devices by Viveve, Inc.

K180584Viveve RF System, Secure K213814Viveve 2.0 System

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Official Source

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