Cold Laser News

In a letter from the FDA dated October 29, 2007 it is clearly stated that the TerraQuant Cold Laser has received FDA clearance with 510(k) premarket notification. This gives the TerraQuant Lasers permission for sale over the counter to anyone who is in need of such a therapeutic device.

The following quote is from the above mentioned letter by the FDA to Medical Quant:

“This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.”

For evaluation purposes it is helpful to understand that there are two types of FDA clearance:

1. The NHN code implies that NHN devices treat pain by non-heating true laser diodes, along with studies that show this to be true.
2. The ILY code is applied to devices which have been shown to produce a sufficient level of heat to induce therapeutic results such as equivalent to light emitting diodes (LEDs). Attaining either clearance allows the manufacturer to market their product in the US.

There is currently no distinguishing code or approval process for devices that contain both true laser diodes and LEDs, and consequently the manufacturers of these type of devices (including the TerraQaunt Lasers) can choose to apply for an FDA clearance under either code. The importance of having FDA clearance is to show that the laser is safe for use by human beings. FDA clearance does not have anything to do with a laser devices effectiveness, which is determined by other factors. The TerraQuant Lasers were determined by the FDA to be Class I non-significant risk devices.

To allow for further understanding in the process of comparing and contrasting cold laser, it is important to realize that a company can choose to get an FDA clearance the easy way or the hard way.  While the easy way is not exactly “easy”, the “hard way” is time consuming and expensive. Only two companies have done it the hard and expensive way and they were the first two companies in the US to receive a cold laser clearance in 2002. Since then all other companies to date have chosen the “easy” way to FDA clearance. Is that surprising? No it is not! Why? Because time is money and getting a product to market in a timely manner is often critical to the success of a company.

Regardless of representations by some other cold laser companies, the educated conclusion is that lasers can not be judged by their FDA clearance. Cold lasers must be judged based on their performance, their power output, previous use and results, wavelengths, frequency capabilities and user friendliness design.

The TerraQuant Laser has nearly 20 years of proven track record in over 30 countries and thousands of hospitals, clinics and private practices, plus the special forces of 7 countries and national sports teams including the NBA, National Soccer Teams, Olympic Athletes and by Acute and Chronic Pain Sufferers worldwide.

The TerraQuant Laser utilizes the slightly warming LEDs and SLD for gentle surface healing, and pain relief features, which gained it FDA clearance under ILY, and it also incorporates the most powerful 15,000 to 25,000mW true laser diodes of the 905 nm deep penetrating wavelength for the deepest and safest penetration of of all cold laser products, thanks to the advanced super pulsed laser technology that it incorporates. Super pulsed laser is the new standard of laser emission technology for pain relief, and is the direction that other competing laser manufacturers are moving towards, because it is recognized by the international laser community as a superior delivery method of photonic laser energy to target tissue up to 5 inches into the body, bones, tendons, ligaments and thick muscles.

When evaluating and comparing the effectiveness of a cold laser, it should not be dependent upon what kind of FDA clearance it has. It should be dependent upon the actual parameters of the healing device such as wavelength, power density, pulse type, frequency, user friendliness of the design and type and quantity of laser diodes or LEDs, or combination of such that are used.

Sadly there are companies that use their FDA clearance to bad mouth other companies that do not have the NHN clearance. To put things into perspective, let’s look at these devices briefly without stating their name brand, so that we can see why they differ and what they offer:

1. One of the companies uses the 830 nm wavelength with three 33 mW diodes and no frequency medicine or pulsing capabilities. This is basically a rudimentary continuous wave laser with a total of 100 or less mW of power focused on 3 points. Consequently, not so good for specific, focalized acupoint treatments, but okay for general pain management, such as for carpal tunnel syndrome (CTS), which is what it is FDA cleared for. Many lasers will work well for treatment of CTS.
2. The other company utilizes the 635 nm wavelength and only has 2 or 4 diodes with a power of just 5mW each. Even with 4 diodes that is only 20mW total maximum power. Numerous practitioners have told me that they regret paying such a high price for such a low power laser with poor penetration depth capabilities. I think that this company with it’s high prices is still banking on the fact that the laser was the first in the US to receive an FDA clearance. Fortunately we have many more great lasers to choose from now than we did in 2002.  We now have great performing lasers with exciting and innovative features at competitive prices.

VISIT QUANTUM-HEALING-LASERS.COM for the best selection of affordable cold lasers.