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Discovering FDA Approved Laser For Pain

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.

The product emits monochromatic radiation by using light amplification which is coherent and collimated. The process emits energy through wavelengths of infrared or other sources which provide a non-thermal and non-heated effect. In all cases, the product can be used without the need for associated topical or other forms of heat.

While a number of other similar products are on the market in other countries and some areas of the United States, few have received approval from the FDA or other organizations. As such, those products have not been designated as being non-thermal or non-heat bases sources. In addition, while some of these products may relieve pain, most lack the safety requirements compared to 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 most companies which obtain these products from mass producers, multi radiance super pulsed lasers are often produced using new and innovative technologies in which direct light energies are aimed at tissue to increase circulation and relieve discomfort. In doing so, the light provides wavelengths which result in better absorption and deeper penetration to relieve discomfort.

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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