Sonendo Gentle Wave System
K-Number: K153157 · 2016-01-29
Device Summary
Frequently Asked Questions
What is the Sonendo Gentle Wave System?
Sonendo Gentle Wave System is a medical device that received FDA 510(k) clearance on 2016-01-29. The listed applicant is Sonendo, Inc.. The 510(k) number is K153157.
When did Sonendo Gentle Wave System receive FDA 510(k) clearance?
Sonendo Gentle Wave System received FDA 510(k) clearance on 2016-01-29, under 510(k) number K153157.
Who is the listed applicant for Sonendo Gentle Wave System?
The FDA 510(k) record lists Sonendo, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sonendo Gentle Wave System?
The FDA product code for Sonendo Gentle Wave System is ELC.
Other records listing Sonendo, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: ELC)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.