Sonendo GentleWave System
K-Number: K160905 · 2016-06-03
ApplicantSonendo, Inc.
Decision Date2016-06-03
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Sonendo GentleWave System is a medical device manufactured by Sonendo, Inc.. It received FDA 510(k) clearance on 2016-06-03 under approval number K160905. 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 Sonendo GentleWave System?
Sonendo GentleWave System is a medical device that received FDA 510(k) clearance on 2016-06-03. It is manufactured by Sonendo, Inc.. The 510(k) number is K160905.
When was Sonendo GentleWave System approved by the FDA?
Sonendo GentleWave System received FDA 510(k) clearance on 2016-06-03, under approval number K160905.
What company makes Sonendo GentleWave System?
Sonendo GentleWave System is manufactured by Sonendo, Inc..
What is the FDA product code for Sonendo GentleWave System?
The FDA product code for Sonendo GentleWave System is ELC.
Other Devices by Sonendo, Inc.
Related Devices (Code: ELC)
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.