The CytonPro-5000 receives 501(k) clearance from the US FDA

The CytonPro-5000 received 501(k) clearance from the US Food and Drug Administration in August 2022. 510(k) clearance from the FDA gives a manufacturer permission to market its product in the United States, and this FDA clearance is a significant milestone for CytonSys.

The CytonPro-5000, CytonSys’s flagship laser product for photobiomodulation light therapy is intended for use in hospitals, clinics, and research institutions, so this clearance opens the way for a significant increase in these institutions adopting the CytonPro-5000. Operating at 1064 nm and with a maximum power of 800 mW/cm², the CytonPro-5000 has proven effective in initial use cases. Some recent impacts of laser light therapy include improved neurological function, treatment of long Covid conditions, and cellular regeneration. Visit the CytonPro-5000 product page for more information.