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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Ultrasonic
510(k) Number K190359
Device Name Sonendo GentleWave System
Applicant
Sonendo, Inc.
26061 Merit Circle
Laguna Hills,  CA  92653
Applicant Contact Eric Simon
Correspondent
Sonendo, Inc.
26061 Merit Circle
Laguna Hills,  CA  92653
Correspondent Contact Eric Simon
Regulation Number872.4850
Classification Product Code
ELC  
Date Received02/15/2019
Decision Date 03/16/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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