ML 830 Cold Laser

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THE ML83O COLD LASER

One of the most fascinating and used healing advances is the MicroLight 830 low-level laser. We are pleased to announce that the MicroLight 830 has received FDA clearance for the treatment of Carpal Tunnel Syndrome. The full announcement of the MicroLight is as follows: HOUSTON (BUSINESS WIRE)–Feb. 11, 2002–MicroLight Corporation of America announces receipt of market clearance from the Food and Drug Administration for the company’s ML83O “Cold Laser” for use in the non-surgical treatment and management of carpal tunnel syndrome or “CTS.”

” CTS sufferers are now free to seek relief from hand and wrist pain through a new non-invasive form of therapy before resorting to surgery,” stated Mike Barbour, president of MicroLight Corporation of America. “FDA market clearance for the ML83O resulted from working with FDA examiners over the past ten years to ensure continuing compliance with the law,” says Barbour. He estimates that more than $4 million was spent in this effort. “Our ML83O successfully performed in several double blind studies and in many clinical trials where some rather substantial parties were involved, including Baylor College of Medicine and General Motors,” he added.

” We are pleased that the FDA market clearance allows commercialization of this important “cold” laser technology,” stated Fred A. Simpson, MicroLight’s executive vice president. MicroLight Corporation of America is seeking strategic partnerships to manufacture and market the ML83O’s CTS application and to develop other clinical applications for the ML83O. “The ML83O has potential for other soft tissue applications,” says Simpson.

Carpal Tunnel Syndrome is the number one repetitive stress injury in America today and is a leading cause of worker lost time and disability. More than one million Americans acquire CTS symptoms each year, and over 200,000 surgical procedures are performed in the treatment of CTS at an annual cost of over $10 billion. Private insurance companies and governmental health plans bear most of that cost.

Although CTS can begin suddenly, its onset is usually gradual. If not treated, CTS may lead to reduced hand function with possible permanent nerve and muscle damage. With early diagnosis and treatment, however, complete recovery usually occurs. Anything that causes swelling of the synovium that surrounds wrist tendons, or produces repeated pressure on the median nerve, can lead to CTS or make it worse if the condition already exists. It should be mentioned that when a medical drug or device is approved for use with a particular condition (this is the usual FDA procedure), the doctor has the option of using it for other conditions if in his medical opinion, it is indicated. While the FDA has cleared the device for Carpal Tunnel Syndrome treatment, their are many other exciting possibilities for this device, which should be available in the near future, through future clinical studies.

In our experience the MicroLight 830, which has been affectionately called “the world’s most expensive flashlight,” has a multitude of uses. Perhaps the most appealing single factor about this unit is the possibility that it may help conditions where all previous therapies have failed. We are certain you can readily see how such an attribute would endear this unit to any dedicated practitioner. Besides this, it is small (will fit into a coat or pants pocket), portable (since it is battery operated), will work through light clothing and requires no special creams or gel (like ultrasound) to do its best.HOW DOES THE ML83O WORK?

ML83O Laser is a non-thermal laser capable of penetrating deep into tissue. Once delivered, the light energy promotes the process of photobiostimulation. In human tissue the resulting photochemical reaction produces an increase in the cellular meta-bolism rate that expedites cell repair and the stimulation of the immune, lymphatic and vascular systems. The net result, observed in clinical trials to date, is the apparent reduction in pain, inflammation, edema and an over all reduction in healing time.

The ML83O is a GaAlA Laser that has wavelength of 830 nm with a power output of 90 mw. At this wavelength and power the ML83O Laser has a penetration of approximately 5 cm with a 3 cm lateral spread.

 

FACTS ABOUT THE ML83O
• FDA Cleared for the treatment     of CTS

• Patented Technology

• Insurance Reimbursable

• Non-invasive

• Reduces Inflammation

• Stimulates Nerve Function

• Backed by 12 years of
Clinical Research

            FILES FOR DOWNLOAD
 General Motors Study, Low Level laser Therapy in the Treatment of Carpal Tunnel Syndrome. (January 25, 1995)

 510k summary, from FDA website, including Microlight 830 study & FDA approval letter. (Feb 2002)

 Operating Manual for the ML83O Laser

For more information about purchasing a Cold Laser, please call Lorri Glick for a free consultation.

Phone: (727) 341-1200

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