Disclaimer #1:

(INVESTIGATIONAL DEVICE, LIMITED BY UNITED STATES LAW TO INVESTIGATIONAL USE): The Medical Device is not cleared by the FDA for commercial distribution in the United States. Therefore, it is NOT AVAILABLE FOR COMMERCIAL SALE. The purpose of this statement is only to notify investigators and not to make the device generally available.

This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease

Disclaimer #2:

Disclaimer: All subjects depicted on this website through videos and/or pictures were either part of an IRB-approved study and/or monitored by authorized physicians or hospital staff in a manner equivalent to IRB oversight when using our devices. Proper informed consent and video-release forms was obtained from all participants, and their safety and well-being were prioritized throughout the duration of their device use. The videos are presented for informational and educational purposes only to demonstrate the potential therapeutic effects of our technology under appropriate medical supervision. Individual results may vary, and these videos should not be interpreted as a guarantee of treatment outcomes. Our company is committed to conducting ethical research and adhering to all necessary regulations and guidelines to ensure the protection of human subjects involved in the development and testing of our devices.