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FDA 510(k) Applications Submitted by SONENDO, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K133752
12/09/2013
SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT
SONENDO, INC.
K130025
01/03/2013
SONENDO ENDOTHERAPY SYSTEM
SONENDO, INC.
K160905
04/01/2016
Sonendo GentleWave System
SONENDO, INC.
K153157
11/02/2015
Sonendo Gentle Wave System
SONENDO, INC.
K190359
02/15/2019
Sonendo GentleWave System
Sonendo, Inc.
K181922
07/18/2018
Sonendo Material A
Sonendo, Inc.
K143448
12/02/2014
Sonendo GentleWave System
Sonendo, Inc.
K211995
06/28/2021
Sonendo Filling Material 5C
Sonendo, Inc.
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