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Our reply to Hairmax Forum message

Recently we received a lot of emails asking us about our response to one of the message posted at Hairmax Forum. With such an amount of general public interest generated we felt the need to publish our response here, for the benefit of the all. Our objective is not to get involved in any public debate. We merely like to clarify some misleading information about the Leimo as stated in the Hairmax Forum message. 

The text in Blue is the message posted on Hairmax Forum whereas our reply is in Red.
Text in Blue as published at Hairmax Forum on 7th January 2005

LaserComb versus Leimo.

The HairMax LaserCombTM is the first and only consumer Laser product to bring the benefits of Laser PhotoTherapy to a handheld portable device for use in the comfort and convenience of your own home. Recently a Korean company has introduced the Leimo and is comparing it to the HairMax LaserComb.
 

We do not compare the Leimo with the Hairmax laser comb. In-fact we make it a point to emphasis the differences.

The truth is that they are two very different products and the LED strips in Leimo cannot be efficacious for treating problem hair. This is Firstly, the Leimo is predominately a low powered LED device, which is in no way as effective as a Laser or the HairMax LaserComb. The Leimo is not a low powered LED device but a Laser and LED therapy device.  The main difference between a Laser and an LED is that Lasers produce coherent light and LEDs do not. Coherent light in Lasers is visible by a speckling effect and is essential for PhotoBioStimulation. Additionally, Laser Light maintains the same energy output over long distances whereas LED’s energy output decreases as a function of the distance away from the LED. There are in-depth debates on the internet about Lasers versus LEDs and the most comprehensive may be found at http://www.acupuncturetoday.com/archives2004/aug/08rindge.html  

It is our opinion that the most comprehensive debate on LED vs Lasers are published at http://www.laser.nu/lllt/laser_discussion.htm whereas the article in Acupuncture Today.com can only be classified as a single person's opinion albeit objective , might not be correct.   The writer quoted Jan Tuner and Lars Hode and their book Laser Therapy, Clinical Practice and Scientific Background. In the same book Jan Tuner and Lars Hode actually pointed out that "the point to note is not that LEDs is not working but that when compared with Lasers , it seems that one can always obtain a better results with Lasers than with LEDs." From this statement and conclusion of clinical test carried out by Jan Tuner and Lars Hode with LED and Lasers we are clear that LED does work, but Lasers are better. This is the main reason the Leimo gives users the best of both worlds - both Lasers and LED.

Additionally, Leimo only contains one weak unfocused Laser diode. There are no such things as "unfocused" laser diode. There are no "weak" lasers. Different lasers does have different power output depending on therapy purposes. Anyway the Hairmax Laser Comb also have only one laser diode. The LaserComb produces 9 Laser beams. Even if they were the same power level, which they are not, it would take you 9 times as long to treat you hair with Leimo as it does with the LaserComb. This sentence is absolutely misleading and makes no sense. Splitting the single beam from a single laser diode into 9 beams as in the case of the Hairmax does not increase the power output nor makes the laser therapy more effective. Furthermore lasers must be kept as close to the treatment area as possible as laser energy decreases with distance. Splitting the laser beam from a single laser diode could lead to a lost in energy absorption. 

The scientific data highlighted by Leimo on their website, especially the data provided by Tina Karu, is misleading . Tina Karu’s research and publications are based on Low Level Lasers not LEDs. Yes Tina Karu's research and publications are based on Low Level Lasers and the Leimo is also a Low Level Laser device.  Also, the NASA research that is cited is based upon high powered LEDs. The Leimo’s LEDs are outputting approximately 0.026 milliwatts of power which is less then 1/10th the energy output of the LaserComb. If you compare the LED in Leimo with Hairmax Lasers , than this sentence is not wrong but misleading. One should compare the lasers in Leimo with Hairmax lasers. We should compare apple with apple. Additionally, the power from the Leimo significantly decreases as it reaches the scalp. The power output of the LED or Laser is an important characteristic of a product because intensity plays an extremely important role in depth of penetration and clinical effects of light. The greater the power, the more deeply light will penetrate through the scalp. If you looked at the light of the LEDs used in NASA’s research you would harm your eyes. The LEDs in the Leimo are of minimal brightness. It is very obvious the writer on time and again compare the Leimo LED with Hairmax's lasers. As mentioned above we should compare apple with apple and never apple with orange.     

On another note if LED are absolutely useless, then why are so many professional lasers manufacturers also produces LED devices, and many also produces LED+Lasers devices? For example the laser comb developed by MKW Lasers in Germany also used LED+Lasers the same device have been used by many well known and international Trichological centres. Thor lasers recently have had 7 new LED probes cleared by FDA .  So if LED are absolutely useless than why are manufacturers continuing producing LED therapy products?

The Leimo web site also states “Leimo have 8 stimulating bars made of urethane rubber serves as a combing device as well as providing stimulating effect liken to massaging and acupuncture of your scalp, this effectively stimulate better blood circulation and thus better hair growth.” What they are referring to are the rubber teeth of its comb. This is absolutely misleading. We are not referring to the "rubber teeth of it's comb". This is the same effect as any teeth on a comb or brush including the teeth on the LaserComb; so it is interesting and misleading that they highlight this as a stimulating effect on hair growth without any basis. The writer claims that we are providing misleading information and that the Leimo's stimulating bars are the same as Hairmax's comb teeth. Well we believe that the truth and facts speaks for itself. The Leimo stimulating bars are made of a special type of rubber - urethane rubber- which is soft to feel and when pressed on the scalp during therapy does not hurt the scalp yet is able to give a "massaging' effect. On the other hand the teeth of the Hairmax is made of a harder type of plastics material, the use of the teeth is to enable users to brush the hair aside so as to allow the laser beam to shine on the scalp.

One other interesting point to note about LEDs is the wavelengths they produce. Lasers, such as the Laser used in the LaserComb produce a very narrow, very specific wavelength of light. This specific wavelength of light, as found in the LaserComb, has been chosen from the full spectrum of light because of the scientifically proven results associated with this wavelength of light. LEDs such as the one used in the Leimo produce a broad spectrum of light with a range anywhere between 30 nanometers to 100 nanometers. For example, the 660nm LED the Leimo states it uses is more like a 610nm to 710nm LED. The narrow bandwidth associated with Lasers and, more specifically the LaserComb, have a great advantage over LEDs that offer a wide spectrum of light.

Once again the writer is comparing the Leimo's LED with Hairmax Lasers, comparing apple with oranges, we believe with the sole and only intention to mislead readers. The Leimo is both a LED+ Lasers device. Anyway one cannot compare even lasers with lasers of different devices if the specifications are different. In this case the lasers of the Leimo and that of the Hairmax are of totally different specifications. The writer also writes on wavelength of LED as compared with lasers - we encourage readers to refer to our Lasers & LED Therapy page for more information on this topic.

Leimo conducted their clinical studies on 6 week old mice by trimming their hair and photographing the speed of hair growth. The photographs and clinical evidence of these mice are very questionable. Very questionable ???? This clinical studies are conducted by Phil Sang Chung, M.D, You Chan Kim, M.D.Min Sang Chung, B.S., Sang Oun Jung, PhD, Chung Ku Ree, M.D. at the Medical Laser Research Center, Department of Dermatology, Dankook University, College of Medicine, Cheonan, Korea and was published by the Journal of the Korean Society Plastic & Reconstructive Surgeons 2004. Questionable or not the public are the best judge. The researchers did not study any causes of hair loss in humans, specifically Androgenetic Alopecia (male of female pattern hair loss) ,the most common form of hair loss in humans or any other hair disorder. All of the LaserComb clinical studies have been performed on actual men and women who are suffering from hair loss. Yes our initial clinical studies are on mice and we are preparing for more studies on human.

It is interesting to note, the Leimo’s “clinical” study on mice tested 3 products against a control group. One group used the Leimo, the other two groups used shampoo. The Leimo had questionable results and the shampoos actually outperformed the Leimo . Read it for yourself http://www.laserhaircomb.com/clinical/leimo.html 

Once again the writer used the words "questionable results". Is this the truth ? We encourage readers to find out yourself. The results of any clinical studies are always summarized in the Abstracts. 

In an effort to stay ahead of the industry Lexington designed, built, and tested a few devices similar to the Leimo, utilizing LED technology. We even filed a patent on our LaserComb design to incorporate LEDs. Our research was conclusive that LEDs did not influence hair regrowth or reduce shedding. We scrapped the LED project and only support Laser devices, such as the LaserComb, that have been proven to be effective.

We tested a Leimo and found that it contains one, very weak, 890 nanometer Laser.
There is no such terms as "weak lasers". The power output of the Leimo is 1.5mW but with the wavelength of 890nm is possible to have the same or even deeper penetration to scalp than the Hairmax. Please read Depth of Penetration Lasers of this wavelength have been used for pain relief but never for hair. Never used for hair does not mean not effective for hair and scalp restoration.  However, the power output of the Leimo is only 0.180 milliwatts, not even strong enough to be effective for pain relief. As mentioned above the power output of Leimo laser is 1.5mW not 0.180 as misled by the writer. The Laser used in the Leimo’s clinical study claims to be a 5 mw laser module, but we have been unable to verify that the diode in the study is being used in their product. No where in the published clinical report did it mentioned 5mW. It was all along publish as a 1.5mW laser (see under heading "lasers source and procedure" in clinical report). Typical power outputs for infrared therapy devices are between 30 and 500 milliwatts which is at a minimum 15 times stronger then that of the Leimo. There isn’t any evidence to date of an 890 nanometer Laser having any effect on the stimulation or growth of hair. All marketed 890 nanometer Laser devices are used for pain management because infrared Lasers produce localized heating. 

The Leimo and its manufacturers are violating United States law because they do not comply with any of the FDA’s safety standards and regulations. The Leimo is a Class 2 medical device approved by the Korean FDA. Do you think the Leimo can be approved by strict Korean FDA regulation if it does not complies with laser safety requirements?  The Leimo declares itself a Class IIIR Laser, but in fact they are a Class IIIB Laser because of the presence of the infrared Laser. Class IIIB Lasers must comply with stricter safety guidelines because of the potential safety hazards associated with these wavelengths. There is evidence that 890 nanometer Lasers, similar to the Leimo, can be damaging to the eyes. The near infrared wavelength at only 1.5mW output power does not emits heat and will never burn the eyes and is also non-invasive. However users must always avoid looking at the laser directly. This precaution have been clearly indicated on the user manual. Furthermore the Leimo set is complete with a laser tester and sensor so that users can test the infrared lasers when the device is turn on.

Leimo does not offer a money back guarantee which speaks volumes for the confidence a company has in their product. If and when you do not find it effective after a few months you have to keep it. To date we have received numerous orders from Leimo users who are dissatisfied. Lexington offers up to a 20 week money back guarantee with each LaserComb.

This is again absolutely misleading and incorrect. The Leimo comes with a 90 days money back guarantee and this can be extended up to 6 months. Similarly we have received numerous orders from Hairmax users who are dissatified.

The Leimo is battery powered and the battery compartment is sealed. If the battery dies, as batteries always do, you will need to discard the unit or send it back to Leimo for replacement. Therefore, the Leimo’s lifespan is short. The LaserComb uses a separate power adapter and shelf life is estimated to be 10-15 years. You never have to worry about battery failure or replacement. Does it mean that product powered by battery have a shorter product life than those powered without battery? This sentence have absolutely no truth in it.   

Please take the time to learn about Lasers and read about the differences between the two products. If you have any further questions our knowledgeable staff will be happy to assist in answering your questions.

End of Hairmax Forum message

 

Our Conclusion 

Any "claims" that Lasers and LED is not working by a manufacturer that develops laser therapy device is a slap on their own face.  It is our opinion that no manufacturer or company should conclude that red visible wavelength is better than infrared wavelengths in hair and scalp therapy without conducting any scientific and systematic research to prove such stated facts (and vice versa).  It's the same with the coherent and non-coherent issues - LED Therapy. There are many professionals lasers manufacturers that produce LED devices for bio-stimulation applications. 

No where on our website did we never claim that other laser hair therapy devices do not work. On the contrary we quoted a few other clinical reports using various laser hair therapy devices including the Hairmax Laser Comb, showing the positive effects of laser irradiation on hair and scalp restoration. 

At this point of time we are of the opinion that no one company can conclude absolutely that lower wavelength RED lasers are certainly better than an infrared high wavelength lasers for hair and scalp therapy, and vice versa, without any systematic clinical research. What we did was to conduct our own clinical trial using 890nm on mice hair growth , and it seems that the results are satisfactory. ( see clinical studies ) Similarly , Satino and others [1] performed a LLLT test with a red 630nm device at 4.5mW power output, on 35 patients with androgen alopecia (28 men and 7 women) in 2003 and also reported satisfactory results. In 1984, Dr. Trelles showed in one study that patients with alopecia areata who were treated with He-Ne laser 632.8 nm showed a good response. In 1996 Professor Pekka J. Pöntinen established established the beneficial effect of laser therapy on hair and scalp showing an increase in blood flow by 54%, using a device at 670 nm. 

However we must acknowledge that devices used by Dr. Trelles and Professor Pöntinen are professional laser therapy devices of a higher power density output. The basic general guideline is also that the higher the power output the deeper the penetration level.  For example , a laser with wavelength of 850nm , power output of 200mW will have a deeper penetration level than a laser with wavelength of 850nm but with a power output of just 50mW. Hence devices used by both Dr. Trelles and Professor Pöntinen although are at Red visible wavelength should afford a deeper penetration liken to an infrared device. 

The Leimo is designed for personal home use designed as a very low power output laser device. This lack of power density are off-set by the use of higher wavelength at 890nm.    

All researchers acknowledge the fact that hair started to grow on the laser-irradiated area does only indicate the relevance between low powered laser irradiation and the stimulation of hair growth. These trials can only provides the suggestion of the possibility of the use of lasers to treat hair loss. Indeed further research are still needed to find the effect of low-powered laser treatment on human hair growth and how the laser stimulates hair growth. In short we need to find out the biological and physiological effect of laser irradiation on hair and hair cells. 

Hence we cannot conclude that Red visible wavelength is better than 890nm or vice versa. What we did was to combine both LED Red 650nm and Infra 890nm to give users the best of both world - Lower wavelength of RED LED and higher wavelength of 890nm lasers. We also offer a chance for users to try and a chance to return after 90 days if results are not satisfactory.

 

1] Satino JL, Markou M. Hair regrowth and increased hair tensile strength using the HairMax LaserComb for low-level laser therapy. Int J Cosm Aesth Dermatol 2003;5:113-117 

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