Registered with the U.S. FDA
The RX1 is registered with the U.S. Food and Drug Administration and cleared for commercial sale in the United States. FDA clearance confirms the device has been reviewed for safety and effectiveness for its intended use as an at-home photobiomodulation device.
- FDA Establishment Registration Number: 3015287734
- Cleared for commercial sale in the United States
- Listed as an at-home photobiomodulation device
Full documentation available on request. Contact support@revogenlab.com.