Based on communication with the U.S. Food and Drug Administration (FDA), the T-8000 Aqueous Ozone Unit has been classified as a medical device subject to premarket notification (a.k.a. 510k review). In order to comply with FDA’s request, TherOzone USA ceased the marketing or repair of T-8000 effective April 2011.
Currently TherOzone USA, Inc. is in the process of compiling the premarket notification application and anticipates receiving FDA clearance within the next 3-4 months or by Fall 2012.
We appreciate our customer's patient and support during this interim. As milestones are reached we will keep you informed.
If you have any questions or concerns, please feel free to contact us at (310) 450-4114.
James E. Shenberg, DDS