Key Insights On Selecting Lasers For Your Practice

Taking a critical look at manufacturer claims, this author provides keys to differentiating between heating and non-heating lasers.

As a practitioner, I am constantly being bombarded by ads, sales representatives and articles stating how great laser therapy is, and that lasers can treat almost every condition in the world.

I believe regenerative medicine is the future of medical technology. We all want a modality that can get good, consistent results. This will not only help our patients but also create a referral basis due to the investment we have made by adding new technology to our practice.

I have spoken with several manufacturers and have a list of questions I ask before making a decision to spend money on any equipment, including laser therapy. One of questions is as follows: is this device cleared by the Food and Drug Administration (FDA) for the indication that is advertised or am I getting a bait and switch?

We have all seen the advertising blitz on toenail fungus lasers and laser therapy for plantar fasciitis. If the technology is that great, the company behind the device should have published research and a FDA 510(k) market clearance that supports the claimed indication along with the results and a proven protocol base on published research.

If devices do not have FDA approval for marketed indications or companies cannot provide a blinded and controlled clinical trial, the manufacturers of these devices are selling their device unethically. Is this something I really want to expose my patients and reputation to? Can you really trust a salesperson or manufacturer that has an approval for one indication but markets a product for another?

I have chosen to be part of several clinical trials and can speak from experience. When someone asks me which laser to buy, I always advise the questioner to look at the published research and the 510(k) marketing statement from the FDA. This will give an idea if the company is ethical or if it is just trying to get a sale.

What most physicians do not know is that for 510(k) applications reviewed in the Office of Device Evaluation, the FDA only requests clinical data for less than 10 percent of submissions.¹ My question would be: where do these protocols come from? Do you think the FDA would ever approve a drug this way?

There are two types of therapeutic lasers that the FDA regulates and they have two different regulatory pathways. The FDA designates lasers with product code ILY as indicated for topical heating and muscle relaxation and designates the product code NHN for low level laser therapy. I think it is important to understand the difference before you invest in this technology.

Pertinent Insights On Topical Heating Lasers

In regard to devices in the aforementioned ILY category, the mechanism of action is heat and not biostimulation as many of the manufacturers claim.² The ILY category has been around for over 40 years, was originally based on a heat lamp used for topical heating and was grandfathered in before the Federal Food, Drug and Cosmetic Act of 1976. You owe it to yourself to do a little research on the FDA website.

To obtain a 510(k) market clearance from the FDA in this ILY category takes approximately 90 days after submission and requires no research. If you remember diathermy from the 1980s, The FDA 510(k) clearance was for therapeutic deep heating.³ Since diathermy and heat lamps both heat the skin, the FDA allowed the indication for diathermy and heat lamps without providing any clinical data. This is called “FDA creep” and is how some devices get approval without any clinical research. How many of you are using a heat lamp and diathermy therapy on your patients? I think you can see where this is headed.

To get a device through the FDA, manufacturers are creative and approach the FDA about new technology, which is how some of the high-powered lasers got 510(k) market clearance. What one should consider is that from an FDA and an efficacy perspective, there is no difference between a heat lamp, diathermy and a $40,000-plus laser that heats the skin. Just look at the 510(k) marketing statements and they are exactly the same.²

Can you imagine if the salesperson were honest and informed you that “You can buy my laser with no research, no proven efficacy and is based on heat lamp technology”? Would anyone ever buy these lasers? The manufacturers get creative. Just look at all of the claims in our trade magazines, e-mails or tradeshows.

If you visit the websites of those high powered lasers companies that market devices in the aforementioned ILY category, they will make various claims about their mechanisms. If you do a little research, these companies will state an infrared laser creates a biological effect but if you look at the cited research, results were based on low level laser therapy that used less power. As Tuner and Hode state, “In a similar vein, purveyors of class IV laser find it suits their purpose to refer to low level laser therapy as evidence of their effect and benefits (largely because there has been very little research into the effects and efficacy of high powered laser therapy) but then go on to claim that 3b lasers are obsolete and that they’ve been surpassed by Class IV devices).”⁴

Watch out for phrases like “greater power means greater penetration.” What makes a claim like this even more amazing is that these devices have been FDA 510(k) cleared for topical heating.

Biostimulation is well documented and has a peak around 10 J/cm². With a 10-watt laser, it would take 1 second to reach this threshold. Huang and colleagues wrote an article on biphasic dose response and stated that “low level laser is good for you and high power is bad for you.”⁵ Anyone buying a laser or treating a patient with laser therapy should read this article.

What You Should Know About Low-Level Lasers

The FDA created the NHN category in January 2002. The mechanism of action is biostimulation and these lasers do not cause any heating of the tissue. Up until 2002, low-level lasers were experimental and one company (Erchonia) was required to do two blinded and controlled clinical trials on chronic neck and shoulder pain to receive FDA market clearance. It took years to get the clearance from the FDA since the company had to perform level 1 clinical trial to obtain 510k market clearance.

There are very few lasers in this category because the FDA requires blinded and controlled clinical trials to obtain market clearance. This research is expensive. It is much easier to build a high-powered laser, skip the research, go to market and then make claims like all of the high powered lasers in the ILY category.

I started researching low level lasers in 2009 and wanted to prove to myself that these devices were efficacious. I approached Erchonia and stated my goals. The company suggested that we perform a level 1 clinical trial and look at obtaining FDA market clearance for the treatment of chronic plantar fasciitis. I also approached a respected friend, Michael Coughlin, MD, with my thoughts regarding using this device for this chronic degenerative condition. He was intrigued by the concept of non-invasive mitochondrial biostimulation for this condition and became a co-investigator. Our goal was to establish clinical evidence based on a double-blind study as no such 510(k) market clearance looking at laser treatment of chronic plantar fasciitis existed at that time.

From the start of the research project to obtaining FDA 510(k) market clearance for plantar fasciitis, it took about three years. The research results were published in the Journal of Foot and Ankle Surgery.⁶ The patients had follow-up for an additional year after the completion of the study. To this date, this study remains the only double-blind research laser study to obtain FDA 510(k) market clearance for chronic plantar fasciitis. You would never know this by the trade publications as other laser companies making this claim are marketing their devices without 510(k) clearance and no research. I am not the FDA but I am trying to make the reader aware of the deceptive and misleading advertising that fills our publications.

Key Insights From The Author’s Experience With Lasers

I see laser therapy as an adjunctive treatment to many conditions that I treat in my office. The laser works well as a standalone treatment but as a researcher, I am always looking to expand my knowledge and efficacy for my patients, combining this technology with other techniques. I have developed my own protocols based on the plantar fasciitis clinical trial and continue to perform research on various conditions.

I started using lasers on patients with peripheral neuropathy and did some research looking at small nerve fiber regeneration. This has led to another blinded and controlled research project that we hope to finish and obtain FDA approval for in 2016. I do this research to help establish evidence-based protocols and establish that this non-invasive technology has potential in improving patient outcomes. We are just now getting a better understanding of the multiple benefits that we can offer our patients with this non‐invasive technology.

Regenerative medicine is the future and we must all embrace this concept if we are to compete. Low-level laser technology is an excellent segue into regenerative medicine. Educate yourself in these technologies and you will be able to offer your patients non-invasive alternative treatment options.

Dr. Zang is a Diplomate of the American Board of Podiatric Surgery, and a Fellow of the American College of Foot and Ankle Surgeons. He is an Adjunct Professor of Surgery at Midwestern University in Phoenix. Dr. Zang is in private practice at the Arizona Institute of Footcare Physicians.

References

1. Food and Drug Administration. The 510(k) program: evaluating substantial equivalence in premarket notifications. Available at https://www.fda.gov/downloads/MedicalDevices/.../UCM284443.pdf . Published July 28, 2014.

2. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=890.5500 . Published April 1, 2015.

3. Food and Drug Administration. Available at https://tinyurl.com/h3zovt3 .

4. Tuner J, Hode L. The Laser Therapy Handbook: A Guide for Research Scientists, Doctors, Dentists, Veterinarians, and Other Interested Parties Within The Medical Field. Prima Books, Coeymans Hollow, NY, 2004, pp. 497-98.

5. Huang YY, Chen ACH, Carroll JD, Hamblin MR. Biphasic dose response in low level light therapy. Dose Response. 2009; 7(4):358-83.

6. Macias DM, Coughlin MJ, Zang K, et al. Low-level laser therapy at 635 nm for treatment of chronic plantar fasciitis: a placebo-controlled, randomized study. J Foot Ankle Surg. 2015; 54(5):768-72.