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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