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FDA 510(k)

Viveve 2.0 System

K-Number: K213814 · 2022-02-02

ApplicantViveve, Inc.
Decision Date2022-02-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Viveve 2.0 System is a medical device manufactured by Viveve, Inc.. It received FDA 510(k) clearance on 2022-02-02 under approval number K213814. 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 2.0 System?

Viveve 2.0 System is a medical device that received FDA 510(k) clearance on 2022-02-02. It is manufactured by Viveve, Inc.. The 510(k) number is K213814.

When was Viveve 2.0 System approved by the FDA?

Viveve 2.0 System received FDA 510(k) clearance on 2022-02-02, under approval number K213814.

What company makes Viveve 2.0 System?

Viveve 2.0 System is manufactured by Viveve, Inc..

What is the FDA product code for Viveve 2.0 System?

The FDA product code for Viveve 2.0 System is GEI.

Other Devices by Viveve, Inc.

K162547Viveve System K180584Viveve RF System, Secure

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Official Source

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