Class 3B vs. Class IV Lasers

SUMMARY

 

• Class III therapy lasers are making a large number of FALSE claims against Class IV therapy lasers in an effort to discredit them

• The FDA regulates and monitors all lasers regardless of classification

• Class IV therapy lasers are safe and clinically effective

• Class III therapy lasers also make false claims regarding dosages, depth of penetration (super pulsing) and overall usage and clinical effectiveness

• Depth of the therapy laser treatment is determined by the wavelength and is stated in Nanometers (nm)

• Speed of the laser therapy treatment is determined by the power in Watts

• The warm temperature that is felt on the skin from a Class IV therapy laser is determined by the combination of the wavelength and power

• The heating of the skin is superficial, not long lasting and only heats up the outer dermis and epidermis

• The Mechanism of Action (MOA) of the LASER is the stimulation of the cell and increased production of APT to help heal the inflamed cells

• Only inflamed cells will respond to the LASER Treatment.  Healthy cells do not recognize the LASER Stimulation. The photons, if the cell is not inflamed, will pass through and go to wavelength depth and dissipate in the tissue

• A key to clinical success is dosage and providing higher dosage levels that may be required to achieve this

 

 

CLASS IV LASERS ARE NOT SAFE - A FALSE CLAIM

Due in part to a large loss of sales in the medical market, many Class III laser companies are promoting a number of false claims on the internet against Class IV therapy lasers.  In summary they are claiming that Class IV lasers are dangerous, can burn patients and overall not safe to use and yet provide no specific claims or FDA notices regarding any of this.

They then state that Class III therapy lasers are safer, more portable and get deeper and better penetration than Class IV therapy lasers. As they make these false claims, they are ignoring many facts regarding all lasers. 

 

KEY: Class IV therapy lasers are FDA CLEARED and SAFE when provided by a trained medical professional following safety guidelines.  MORE IMPORTANTLY they will generate better and more consistent positive clinical outcomes due to their ability to provide higher dosage levels, wavelength and treatment beam size.
 

ALL LASERS REQUIRE FDA CLEARANCE “510K”

All lasers - both medical and non-medical - are regulated by a division of the FDA - the Center for Devices for Radiological Health (CDRH); with their purpose and focus on "safety", primarily eye safety. The FDA issues a formal letter for each laser cleared for use and sale that are referred to as an “FDA 510K”.  Each 510K also states the “cleared indications for use” and also the “usage status” for use by licensed medical professionals (Rx) or for use by consumers (OTC).

 

FDA TAKEN ACTION AGAINST CLASS IV THERAPY LASERS

The first Class III therapy laser was given an FDA 510K in 2001 and the first Class IV therapy laser was given an FDA 510K in 2003.  If Class IV therapy lasers were as unsafe as they claim, the FDA would have taken action and forced changes regarding the sale and use of these lasers. To date, the FDA has not taken permanent action against any Class 4 therapy laser company that was based on the lasers being unsafe and causing burning or thermal damage.

 

FDA WARNING LETTERS ISSUED TO CLASS III And CLASS IV LASER COMPANIES

The FDA requires that each Laser Company meet specific quality control requirements (cGMP) and be audited on a regular basis. Any company that the FDA audits that does not meet these requirements are provided a “Warning Letter” that states the deficiencies and a time line to correct them. These are posted publicly on the internet.
 

• Currently MULTIPLE CLASS III THERAPY LASER COMPANIES have been cited by FDA WARNING LETTERS since 2001; with some that have been forced to cease operations, as recent as 2016.

• ONLY ONE CLASS IV THERAPY LASER COMPANY has been cited by an FDA WARNING LETTER since 2003; and has since closed the company voluntarily in 2011.

 

ALL MEDICAL DEVICES HAVE RISK AND REQUIRE SAFE USE

All medical devices are at risk to a patient if used improperly, including Class III and IV lasers. Ultrasound Therapy devices, Diathermy devices and others have been documented to cause deep tissue burns as their mechanism of action is thermal.  Despite this, these devices have been in use for 50 years and yet the FDA has not "removed them" from the medical market. A common contraindication is use over metal implants because of the danger of tissue burning. In contrast, Class IV therapy lasers CAN SAFELY treat over a metal implant.  The reason for this because the mechanism of action is photo-chemical, and not thermal. Class III therapy lasers refer to Class IV lasers as “surgical only”; yet there are many “types” of laser technologies that are Class IV and not used for therapy such as CO2 and YAG lasers/ applications.
 

FDA REPORTING SYSTEM FOR INJURIES CAUSED BY LASERS

The FDA has a Public Reporting System called MAUDE - which reports all "adverse" effects or results from a medical device causing harm or damage. There are actually more Class III therapy lasers (and LED pads) reported in MAUDE than Class IV therapy lasers for patient reports, due in part to the "unattended" use of some of these low power units that have resulted in patients being burned.

The majority of Class IV laser claims are with surgical and aesthetic lasers for various procedures that are much more complex than a therapy laser treatment (such as hair removal, tattoo removal, tissue ablation and removal).

 

KEY: I have personally seen thousands of patients - both human and veterinary - treated over the last 14 years, and have yet to see one single serious burn or tissue damage caused by a Class IV therapy lasers as is regularly claimed by Class III therapy laser companies.

 

CLASS IV LASERS CAUSE OVER-DOSING AND VIOLATE THE THERAPEUTIC WINDOW – A FALSE CLAIM

In a false effort to justify low power levels and low dosages, Class III therapy lasers often quote the "Arndt - Shultz Law" stating that there is a "therapeutic window" and that Class 4 therapy lasers exceed this, resulting in over-dosing. This over-dosing then causes damage to the tissue areas being treated. 

 

The “truth” is that this “law” was originally formulated in the world of pharmacology, has come in and out of favor several times, and now serves as one of the foundations of homeopathy. There is no doubt that there are issues relevant to laser therapy in which this idea applies. But, it is crucial to remember that this is not a “law” at all, nor is it based on fundamental principles or cellular processes, and so to claim that more than X amount of radiation is inhibitory because the Arndt-Schultz law says so, is completely unfounded.
 

Virtually all of the empirical investigations that attempt to narrow the optimal treatment parameters have been performed in vitro.
 

These studies have the advantages that the majority of the parameters can be easily measured and well controlled, and many of the results of these experiments have indeed shown an optimal dose region for biostimulation above which inhibition takes place.

There are, however, inherent limitations in extrapolating these results to conclusions on the effects in bulk tissue, as well as some fundamental shortcomings in the breadth of their investigations.

 

 

THE REALITY OF CLASS III LASERS - GUILTY OF UNDER-DOSING

The reality of Class III therapy lasers is their inability to provide sufficient dosage levels that are required to provide a consistent and positive clinical outcome. The Class III therapy laser companies will quote that there are “over 3,000” clinical studies on the internet for “Low Leve Laser Therapy (LLLT)”. The problem with this is that the CONCLUSION OR SUMMARY of many of these studies show that “LLLT” was not significantly more effective than a “PLACEBO EFFECT,” and are guilty of under-dosing.

 

"The authors of Laser Therapy- Clinical Practice and Scientific Background, Dr. Jan Tun’er and Lars Hode, have performed an analysis of a number of frequently cited studies on the effects of low-power-laser therapy. Selected Quotes:

 

“In many of these studies, analysis uncovered one or more reasons for the negative findings reported, the most common being the use of extremely low doses.”  "The trend in laser therapy for the past 10 years has been to increase power density and dose, since this has been shown to improve therapeutic outcomes considerably.”  “There is no point in increasing the dose if the wavelength has a low penetration factor; the penetration of the particular wavelength must be taken into account." “For the moment, we must rely on our own clinical experience. That experience, however, is so encouraging that it cannot be ignored, even with lack of scientific support. It would appear that “high powered” therapeutic lasers will be able to further expand the scope of laser therapy.” “I can see two alternatives for myself: to speak up and start a conflict within the laser community, maybe discrediting the therapy itself in the eyes of the general public or to keep quiet and let US practitioners pay a lot of money for very low-powered lasers, leaving us with dissatisfied customers and discredit from those who are supposed to use laser therapy in medicine.”

 

Ironically, some Class IV therapy lasers also under-dose, generating some therapeutic benefit, but not achieving the clinical results required.

 

KEY: A key to positive clinical outcomes is dosage and the correct amount of dosage, that will vary from patient to patient and other factors.

 

 

 

CLASS III THERAPY LASERS ARE NOT EFFECTIVE ACCORDING TO THE INSURANCE INDUSTRY

“While the FDA has approved the marketing of the device, many payers have declined to provide recognize LLLT as effective treatment. Results of treatment have not been consistent so that it is difficult to state that such treatment would be necessary. Last, given the reported number of visits required to be nine to 12 visits, the cost of such treatment would be approximately $1000 to $1500. These costs appear to be somewhat unreasonable for a treatment that has not been demonstrated in the medical literature to be effective.”
 

Source:  Position Paper on Low Level Laser Therapy (LLLT) 12 pages
 

Ohio Bureau of Workers’ Compensation
 

http://www.ohiobwc.com/downloads/blankpdf/PositionLaserTherapy.pdf

 

“Aetna considers cold laser therapy experimental and investigational because there is inadequate evidence of the effectiveness of low-energy (cold) lasers in wound healing, pain relief, or for other indications such as musculoskeletal dysfunction, arthritis, and neurological dysfunctions.”
 

Source:   Aetna: Clinical Policy Bulletins, Number 0363, Subject: Cold Laser Therapy

 

CLASS III SUPER PULSING WORKS BETTER THAN CLASS IV – A FALSE CLAIM

Many Class III therapy lasers claim to SUPER PULSE and drive laser energy deep into the body “a billionth of a second”, deeper than Class IV therapy lasers. They do not cite the TESTING EQUIPMENT that can verify this depth of penetration.  They will claim very high “PEAK POWER” levels for example 25,000mW – 50,000mW; appearing to equal a Class IV therapy laser power level, but offering a “safer” treatment. This sounds impressive, but these lasers emit only 10-100 mW AVERAGE POWER, and this is what counts for a clinical effectiveness.  The average power is calculated by knowing the Peak Power, the Pulse Frequency and the Pulse Duration. At 50,000 mW peak power, the Average Output Power is only 0.050 mW, or fifty millionths of one Watt.  With this very low average power it will take twenty thousand seconds (5.6 hours) for this laser to deliver one Joule.  In significant contrast, a Class IV therapy laser provides 6,000 joules in 10 minutes at 10 watts on continuous wave (CW).

 

 

CLASS III SPECIAL FREQUENCIES ARE EFFECTIVE – A FALSE CLAIM

Incorporated into many Class III therapy lasers are protocols that rely on SPECIAL FREQUENCIES to achieve effective results. Many of these frequencies are used to not only treat muscles and joints, but also organs and other areas of the body.

The problem is that many of these “recommended” frequencies employed in therapeutic lasers are, in fact, carried over from other fields and modalities, especially electrical stimulation.  Nogier’s frequencies, for example, are often incorporated into laser therapy protocols for both humans and animals; yet their original application was in humans only, specifically auricular therapy delivered by electrical stimulation. Two major challenges exist, first that no published clinical studies exist to validate and prove the effectiveness of these special frequencies. Second, the FDA has NOT provided an FDA 510K clearance for these applications.

 

CLASS IV THERAPY LASERS ARE THE NEXT GENERATION OF LASER THERAPY

The laws of laser physics have demonstrated that the longer the wavelength, the deeper the penetration. Penetration is paramount in order to stimulate deep musculoskeletal, vascular, lymphatic, and neurological structures. If Class III lasers are therapeutically ineffective, it is because of insufficient energy or dosage, combined with poor penetration. Class IV therapy lasers have the proper wavelength, power level, treatment beam size and operating mode to generate positive clinical results.