Substantial Equivalence Cleared
510(k) is the FDA's premarket notification pathway for Class II medical devices. It requires demonstrated substantial equivalence to a legally marketed predicate device in intended use and technological characteristics. The RX1 completed this process for at-home photobiomodulation.
- Class II medical device clearance pathway
- Substantial equivalence to legally marketed predicate
- FDA Registration #3015287734
Full documentation available on request. Contact support@revogenlab.com.
