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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 K153157
Device Name Sonendo Gentle Wave System
Applicant
Sonendo, Inc.
26061 Merit Cir.
Suite 102
Laguna Hills,  CA  92653
Applicant Contact DAN W. MILLER
Correspondent
Sonendo, Inc.
26061 Merit Cir.
Suite 102
Laguna Hills,  CA  92653
Correspondent Contact DAN W. MILLER
Regulation Number872.4850
Classification Product Code
ELC  
Date Received11/02/2015
Decision Date 01/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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