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FDA 510(k)

Sonendo GentleWave System

K-Number: K190359 · 2019-03-16

ApplicantSonendo, Inc.
Decision Date2019-03-16
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Sonendo GentleWave System is a medical device manufactured by Sonendo, Inc.. It received FDA 510(k) clearance on 2019-03-16 under approval number K190359. 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 GentleWave System?

Sonendo GentleWave System is a medical device that received FDA 510(k) clearance on 2019-03-16. It is manufactured by Sonendo, Inc.. The 510(k) number is K190359.

When was Sonendo GentleWave System approved by the FDA?

Sonendo GentleWave System received FDA 510(k) clearance on 2019-03-16, under approval number K190359.

What company makes Sonendo GentleWave System?

Sonendo GentleWave System is manufactured by Sonendo, Inc..

What is the FDA product code for Sonendo GentleWave System?

The FDA product code for Sonendo GentleWave System is ELC.

Other Devices by Sonendo, Inc.

K160905Sonendo GentleWave System K153157Sonendo Gentle Wave System K181922Sonendo Material A K211995Sonendo Filling Material 5C K203302GentleWave X

Related Devices (Code: ELC)

K161639Y-MICMicron Corporation K160905Sonendo GentleWave SystemSonendo, Inc. K153157Sonendo Gentle Wave SystemSonendo, Inc. K170104COMPACT S, COMPACT S (LED)Dmetec.Co., Ltd. K163414Ultrasonic scalerNanning VV Dental Co., Ltd. K171150AW-100Micron Corporation

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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