GentleWave X

Scaler, Ultrasonic

Sonendo, Inc

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

Pre-market Notification Details

Device IDK203302
510k NumberK203302
Device Name:GentleWave X
ClassificationScaler, Ultrasonic
Applicant Sonendo, Inc 26061 Merit Circle, Suite 102 Laguna Hills,  CA  92653
ContactLyle Verplanck
CorrespondentLyle Verplanck
Sonendo, Inc 26061 Merit Circle, Suite 102 Laguna Hills,  CA  92653
Product CodeELC  
CFR Regulation Number872.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-09
Decision Date2021-02-05

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