Sonendo Gentle Wave System

Scaler, Ultrasonic

SONENDO, INC.

The following data is part of a premarket notification filed by Sonendo, Inc. with the FDA for Sonendo Gentle Wave System.

Pre-market Notification Details

Device IDK153157
510k NumberK153157
Device Name:Sonendo Gentle Wave System
ClassificationScaler, Ultrasonic
Applicant SONENDO, INC. 26061 MERIT CIRCLE, SUITE 102 Laguna Hills,  CA  92653
ContactDan W. Miller
CorrespondentDan W. Miller
SONENDO, INC. 26061 MERIT CIRCLE, SUITE 102 Laguna Hills,  CA  92653
Product CodeELC  
CFR Regulation Number872.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-02
Decision Date2016-01-29

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