Lumen Products Technical Information:
All Lumen Photon Therapy™ devices are FDA cleared and became exempt from the 510(k) requirement in 1997 because of their safety.
The FDA classification code is 890.5500.
200mw 17º infrared LEDs, 4,500 millicandlaria (mcd) visible red LEDs. The effective “as measured” output per diode is 72Mw/cm2 for IR and 5Mw/cm2 for visible red.
All prices are in USD