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FDA Approved Laser For Pain Now Available

By Sandra Cole


While people have been suffering for years from discomfort in the neck and shoulder, this may no longer be the case. For, there is a new FDA Approved Laser For Pain in these and other areas of the body. In June of 2018, the United States Food and Drug Administration approved a laser light based product known as a multi radiance medical MR4 laser.

For after a series of studies with test subjects using an actual product while others used a placebo, there was enough proof in the safety and effectiveness of a new laser that it received approval from the United States Food and Drug Administration. In addition, the product has also received a NHN product classification with FDA clearance which now allows for the use of the product by individuals and clinicians.

Light amplification and other light sources are used to emit monochromatic radiation which is coherent and collimated. By emitting energy through wavelengths and other infrared sources, a non-heated and non-thermal treatment is used to relieve pain without topical heating. The new and technology goes beyond pain relief. For, since there is no heat source such as found in heating pads, there is also a reduction in risk associated with fire or severe burns to the body as can occur with heating pads and similar products.

While a number of similar products are for sale in the United States, few have obtained FDA approval or have been designated as NHN which recognizes the product as being non-thermal. As such, while a number of the products may be effective, most are lacking the safety requirements of those approved by the FDA.

In most cases, companies avoid undergoing FDA approval due to the costly and rigorous process to do so. For, the process involves conducting studies and reporting results to a number of organizations. After which, the product must also undergo a number of tests to support claims related to effectiveness and safety.

Unlike many companies whom mass produce these products, multi radiance super pulsed lasers are produced using innovative technology which delivers direct light energy to tissue increasing circulation and relieving discomfort. In doing so, the light includes wavelengths which allow for better absorption and deeper penetration. As a result, the discomfort is often eliminated for a much longer period of time than when taking medication or obtaining chiropractic adjustments.

Researchers worked with 86 test subjects to determine how light therapies such as phototherapy effected painful areas of the body. The results of a portion of these individuals showed that the technology was more positive than that of associated placebos. After which, participants were asked to return for a one month follow up to determine whether the pain had returned, lessened or subsided completely.

Once having discovered the pain had eased or subsided completely, researchers were fairly sure that FDA approval would be granted. While this is the case, there were also additional studies necessary to determine the safety and effectiveness of the new light based laser therapy on the neck and shoulder of other subjects before approval could be finalized. Once those results also showed positive results, FDA approval was granted, thus allowing clinicians and individuals to relieve pain without harsh narcotics, multiple trips to a chiropractor or painful cortisone injections.




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