Does it seem that every Laser/LED on the web is FDA approved? Here is a bit of history on why.
Microlight Corporation and Erchonia were the first to get FDA clearance back in 2002. Microlight, for example, spent millions of dollars over 10 years, submitting countless research and two double blind studies (Baylor & GM Motors) to get their ML830® cleared by the FDA. Erchonia had a similar situation. To our knowledge, no other laser company has ever received a new specific FDA clearance.
NOW EVERYBODY ELSE…..
Let’s say you had the option to wait years, spending millions of dollars on research/studies or you had an option to basically spend 39 cents on a stamp and get your product FDA Cleared. Which route would you go?
Welcome to the world of LED/SLD/Heat Lamp devices.
THE HEAT LAMP…..
Their is an old FDA clearance on record that states something like this: “Indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation tissue, and to temporarily increase local blood circulation where heat is indicated.”
WHAT DOES THIS HAVE TO DO WITH LASER THERAPY ?
Nothing (LOL). But these clever companies determined they could piggy-back on this heat lamp’s FDA clearance and fool the market into thinking they were buying FDA-cleared lasers. A few companies have even piggy-backed on the ML830® clearance in the last few years.
BOTTOM LINE……
The ML830® Laser has been in the market for about 15 years, with hundreds of studies and research supporting it. Be careful that you are not suckered into buying a LED device that a salesman claims is as good as a ML830® Laser. If he can produce even ONE double blind study supporting his claims, then buy the LED……