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FDA 510(k)

Sonendo Gentle Wave System

K-Number: K153157 · 2016-01-29

ApplicantSonendo, Inc.
Decision Date2016-01-29
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Sonendo Gentle Wave System is a medical device manufactured by Sonendo, Inc.. It received FDA 510(k) clearance on 2016-01-29 under approval number K153157. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sonendo Gentle Wave System?

Sonendo Gentle Wave System is a medical device that received FDA 510(k) clearance on 2016-01-29. It is manufactured by Sonendo, Inc.. The 510(k) number is K153157.

When was Sonendo Gentle Wave System approved by the FDA?

Sonendo Gentle Wave System received FDA 510(k) clearance on 2016-01-29, under approval number K153157.

What company makes Sonendo Gentle Wave System?

Sonendo Gentle Wave System is manufactured by Sonendo, Inc..

What is the FDA product code for Sonendo Gentle Wave System?

The FDA product code for Sonendo Gentle Wave System is ELC.

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Other Devices by Sonendo, Inc.

K160905Sonendo GentleWave System K181922Sonendo Material A K190359Sonendo GentleWave System K211995Sonendo Filling Material 5C K203302GentleWave X

Related Devices (Code: ELC)

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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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