Sonendo GentleWave System

Scaler, Ultrasonic

Sonendo, Inc.

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

Pre-market Notification Details

Device IDK143448
510k NumberK143448
Device Name:Sonendo GentleWave System
ClassificationScaler, Ultrasonic
Applicant Sonendo, Inc. 26061 Merit Circle, Suite 102 Laguna Hills,  CA  92653
ContactJenny Fam
CorrespondentJenny Fam
Sonendo, Inc. 26061 Merit Circle, Suite 101 Laguna Hills,  CA  92653
Product CodeELC  
CFR Regulation Number872.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-02
Decision Date2015-05-01
Summary:summary

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