Regulatory Information

HydoCision®, Inc. is an ISO 13485, FDA registered, medical device manufacturer and marketer.

The Products marketed by HydroCision in the United States have received FDA clearance through 510(k) Premarket Notifications.

The products marketed by HydroCision in the European Union are CE Marked. Products marketed in Canada are Licensed by the Canadian Medical Devices Bureau.

Please contact us at info@hydrocision.com with any questions.
If you wish to obtain a copy of our certificates, licenses, or clearance letters from the FDA, please submit your request info@hydrocision.com.