FDA 510(k)

miraDry System

K-Number: K160141 · 2016-10-31

Decision Date2016-10-31

Product CodeNEY

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

miraDry System is a medical device manufactured by Miramar Labs, Inc.. It received FDA 510(k) clearance on 2016-10-31 under approval number K160141. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the miraDry System?

miraDry System is a medical device that received FDA 510(k) clearance on 2016-10-31. It is manufactured by Miramar Labs, Inc.. The 510(k) number is K160141.

When was miraDry System approved by the FDA?

miraDry System received FDA 510(k) clearance on 2016-10-31, under approval number K160141.

What company makes miraDry System?

miraDry System is manufactured by Miramar Labs, Inc..

What is the FDA product code for miraDry System?

The FDA product code for miraDry System is NEY.

Other Devices by Miramar Labs, Inc.

K180396miraDry 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.