Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GentleWave X

K-Number: K203302 · 2021-02-05

ApplicantSonendo, Inc.
Decision Date2021-02-05
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GentleWave X is a medical device manufactured by Sonendo, Inc.. It received FDA 510(k) clearance on 2021-02-05 under approval number K203302. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GentleWave X?

GentleWave X is a medical device that received FDA 510(k) clearance on 2021-02-05. It is manufactured by Sonendo, Inc.. The 510(k) number is K203302.

When was GentleWave X approved by the FDA?

GentleWave X received FDA 510(k) clearance on 2021-02-05, under approval number K203302.

What company makes GentleWave X?

GentleWave X is manufactured by Sonendo, Inc..

What is the FDA product code for GentleWave X?

The FDA product code for GentleWave X is ELC.

Other Devices by Sonendo, Inc.

K160905Sonendo GentleWave System K153157Sonendo Gentle Wave System K181922Sonendo Material A K190359Sonendo GentleWave System K211995Sonendo Filling Material 5C

Related Devices (Code: ELC)

K161639Y-MICMicron Corporation K160905Sonendo GentleWave SystemSonendo, Inc. K153157Sonendo Gentle Wave SystemSonendo, Inc. K170104COMPACT S, COMPACT S (LED)Dmetec.Co., Ltd. K163414Ultrasonic scalerNanning VV Dental Co., Ltd. K171150AW-100Micron Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑