Complaint / review text:
BioFlex Laser Therapy Devices SCAM
I am a medical laser engineer. I have studied the BioFlex Laser devices and they are NOT lasers. They incorporate arrays of
LEDs, but NO laser diodes. Some of their LEDs may be narrow bandwidth LED light emitters but they are NOT monochromatic laser diode emitters like those used in lasers. LEDs cost just pennies each to buy, but laser diodes cost in the hundreds to thousands of dollars EACH to buy. Their devices incorporate hundreds of "diodes" but not 100's of laser diodes. BioFlex devices are, at best, no more than a glorified "heat-lamps".in fact, the FDA Clearance it (and its Predicate Devices) received is just/only for the "manufacturers claim" of, "to provide topical heating for the purpose of elevating tissue temperature". How can they call them therapeutic medical laser devices, and how do they get away with making all those exaggerated "medical claims" (in direct VIOLATION of FDA rules and Guidelines) when treatments with their devices can give no more benefit than going out, standing in the sun, and getting sweaty?