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FDA 510(k)

Viveve RF System, Secure

K-Number: K180584 · 2018-04-06

ApplicantViveve, Inc.
Decision Date2018-04-06
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Viveve RF System, Secure is the device name listed in this FDA 510(k) record. The listed applicant is Viveve, Inc.. It received FDA 510(k) clearance on 2018-04-06 under 510(k) number K180584. 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 RF System, Secure?

Viveve RF System, Secure is a medical device that received FDA 510(k) clearance on 2018-04-06. The listed applicant is Viveve, Inc.. The 510(k) number is K180584.

When did Viveve RF System, Secure receive FDA 510(k) clearance?

Viveve RF System, Secure received FDA 510(k) clearance on 2018-04-06, under 510(k) number K180584.

Who is the listed applicant for Viveve RF System, Secure?

The FDA 510(k) record lists Viveve, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Viveve RF System, Secure?

The FDA product code for Viveve RF System, Secure is GEI.

Other records listing Viveve, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213814Viveve 2.0 SystemK162547Viveve System

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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