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The
ML830® Laser System from the
MicroLight Corporation of America,
a Texas company, was granted market clearance by the U.S. Food and Drug
Administration in February 2002. That FDA clearance represented a major
breakthrough for medical devices, enabling low level lasers to be used
for the first time in the U.S. (Similar lasers have been used in other
countries for many years.)
The ML830®
Laser, the use for which MicroLight holds a methods patent
from the U.S. Patent & Trademark Office, was unquestionably the
first low level laser granted FDA market clearance in the U.S. for the
non-surgical treatment of carpal tunnel syndrome. Recently, several
other laser companies were granted FDA market clearance for the use of
low level lasers on CTS. However, companies offering those other devices
claim, directly or indirectly, that the ML830® Laser System is their
"predicate" device. In other words, those other lasers claim
to have "substantial equivalency" to the ML830® Laser. If
you look carefully at what those others offer, you may see where their
products either do not exist, or that they are not truly the effective
equivalent, neither in quality nor in the accessories that are included
in the package. Nor do those copycat sellers offer the same important
experienced practitioner training that MicroLight offers to the buyers
of its ML830®.
The truth is that we spent over twelve years developing the ML830®,
incurring the cost of disciplined randomized double blind
clinical studies. We also sought and obtained a U.S. Patent
on the method for using the ML830®.
That patent on the ML830®
was issued to our good friend Chadwick Smith, M.D., a
highly-respected neurosurgeon and professor at the
University of Southern California who lectures frequently on
the merits of our ML830®.
Quite naturally, we intend to take all legitimate steps available to us
to protect our investment in the ML830® and its method patent
position. That total investment at this point is calculated to be in
excess of $4 Million. It is still the case that
companies are marketing lasers that do not have FDA
approval. We are monitoring this on the lookout for
and you should too.
You want "the original". You want a laser from the people who
did the basic research. You want a low level laser you can trust and
depend on. You want the ML830® patented by the MicroLight
Corporation of America. Stay tuned to our website, or call us at Laser
Therapeutic Technology Inc. 800-235-3540 |