Laser Hair Therapy – is it really FDA Approved?

Tue 29 May 2007

Recently there has been a great deal of discussion and controversy about the recent FDA approval of low level laser therapy. Some members of our discussion forum  feel that the marketers of these low level laser hair loss treatments have been misrepresenting this very limited approval for safety by presenting it as if it were an endorsement of their effectiveness in treating hair loss.

In reality the FDA approval for devices like the Laser Max Hair Comb is not based on any measure of their effectiveness as a hair loss treatment. Rather such laser hair therapy devices have merely been FDA approved recently for being non harmful.

Yet the marketers of these low level laser hair therapies have been cleverly touting their products FDA approval in press releases and their advertisements as if it were now proven to be an effective FDA approved hair loss product like Rogaine or Minoxidil.

To learn more about this hot topic and view some of the debate, visit the following discussion forum topic:

What does FDA Approval of Low Light Laser Therapy really mean?

Dr. Alan Feller’s rebuttal of laser hair therapy used by Advanced Hair Studio

Dr. Bauman advocates that laser therapy MIGHT have some benefit.

Pat – Publisher of the Hair Transplant Network, the Coalition Hair Loss Learning Center, and the Hair Loss Q & A Blog. To share ideas with other hair loss sufferers visit our Hair Restoration Discussion Forum.

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14 Comments so far:

  1. Ben says:

    What is the deal with Laser hair regrowth? Does it work as well as the topical solutions? How does this differ from rogaine or caproxen?

  2. Ben,

    Whether or not laser therapy is an effective hair loss treatment has been heavily debated on our hair loss disussion forum. There are some hair restoration physicians who would say that laser therapy is as effective as proven topical treatments such as Rogaine 2% while others believe that it won’t provide any real benefit. After speaking with several leading hair restoration physicians who regularly use laser therapy as a part of their practice, I feel that laser therapy may help prevent further thinning and may increase the number of terminal hairs on the scalp. In my opinion, laser therapy may have marginal benefit in some patients, especially when combined with other proven treatments. In other patients, it may have no effect.

    Best wishes,

    Bill Seemiller
    Associate Publisher/Editor

  3. Mary Allen says:

    Have any of the users experienced any adverse effects such as headaches or disorientations following treatment? How close to the scalp should the laser beams be?

  4. David aka - TakingthePlunge says:


    The most common side effects reported by users of laxer therapy for hair loss include; headaches and itchiness. Less common sides effects may be rashes and nausea.

    In the case of the laser comb, the beams are kept about 1 1/4″ from the scalp by the teeth of the comb.

    Hope this helps,

    David (TakingThePlunge)

  5. Mary,

    If you’re using an at home laser “comb” type product, it’s probably best to read the instructions about how close the laser should be to the scalp. Having said that, one of the most frequent complaints from comb users is headaches (from using the product too aggressively or pushing it to hard into the scalp). However, it may be worth while to discuss the issue and symptoms with your personal physician and ask his or her question on continuing treatment with the laser product.

    I hope this helps!

    Blake (Future_HT_Doc)
    Editorial Assistant

  6. olgasimmons says:

    Has anyone used the X5HairLaser? I hear it’s good, but I am apprehensive about buying one.
    thank you!

    Os in s a.

  7. AP says:

    I am interested in the X5 Hair Laser offered by SpencerForrest…it is not a comb, however. Any thoughts on this new product?
    Thank you!

  8. David aka - TakingthePlunge says:


    The jury is still out regarding the effects of low level laser light on hair regrowth. However, I see no harm in patients adding it to their hair loss regimen as long as they are not disregarding proven treatments like Rogaine (minoxidil) and Propecia (finasteride).

    As with all hair loss treatments, results vary from patient to patient. The only way to know if it will benefit you is to try it.

    David (TakingThePlunge)

  9. I am Leonard Stillman, Director of Professional Services at Lexington International,LLC developers and manufacturers of the HairMax LaserComb. This post is not for commercial purposes, but to set the record straight on some comments made on this blog.

    To begin with, the procedure for gaining clearance of medical devices from the FDA is to prove equivalency to a predicate device. However, what is not known is that some devices, and the HairMax LaserComb was one of them – have to provide proof of clinical safety and efficacy. Lexington International conducted a double blind, sham device controlled clinical study on over 100 male patients that conclusively proved efficacy and safety under not only Good Clinical Practice Guidelines, but under the approval of the protocol of an independent Clinical Research Organization. The results of this clinical study was a key component of the FDA filing and subsequent clearance for marketing by the FDA.

    An article of the published study of the results were published in a independent peer-review journal and the abstract of this article is reproduced below:

    Clin Drug Investig. 2009;29(5):283-92. doi: 10.2165/00044011-200929050-00001.

    HairMax LaserComb laser phototherapy device in the treatment of male androgenetic alopecia: A randomized, double-blind, sham device-controlled, multicentre trial.
    Leavitt M, Charles G, Heyman E, Michaels D.

    Private Dermatology Practice, Maitland, Florida, USA.

    BACKGROUND AND OBJECTIVE: The use of low levels of visible or near infrared light for reducing pain, inflammation and oedema, promoting healing of wounds, deeper tissue and nerves, and preventing tissue damage has been known for almost 40 years since the invention of lasers. The HairMax LaserComb is a hand-held Class 3R lower level laser therapy device that contains a single laser module that emulates 9 beams at a wavelength of 655 nm (+/-5%). The device uses a technique of parting the user’s hair by combs that are attached to the device. This improves delivery of distributed laser light to the scalp. The combs are designed so that each of the teeth on the combs aligns with a laser beam. By aligning the teeth with the laser beams, the hair can be parted and the laser energy delivered to the scalp of the user without obstruction by the individual hairs on the scalp. The primary aim of the study was to assess the safety and effectiveness of the HairMax LaserComb laser phototherapy device in the promotion of hair growth and in the cessation of hair loss in males diagnosed with androgenetic alopecia (AGA).

    METHODS: This double-blind, sham device-controlled, multicentre, 26-week trial randomized male patients with Norwood-Hamilton classes IIa-V AGA to treatment with the HairMax LaserComb or the sham device (2 : 1). The sham device used in the study was identical to the active device except that the laser light was replaced by a non-active incandescent light source.

    RESULTS: Of the 110 patients who completed the study, subjects in the HairMax LaserComb treatment group exhibited a significantly greater increase in mean terminal hair density than subjects in the sham device group (p < 0.0001). Consistent with this evidence for primary effectiveness, significant improvements in overall hair regrowth were demonstrated in terms of patients' subjective assessment (p < 0.015) at 26 weeks over baseline. The HairMax LaserComb was well tolerated with no serious adverse events reported and no statistical difference in adverse effects between the study groups.

    CONCLUSIONS: The results of this study suggest that the HairMax LaserComb is an effective, well tolerated and safe laser phototherapy device for the treatment of AGA in males.

    PMID: 19366270 [PubMed – indexed for MEDLINE]

    It is important to realize that the HairMax LaserComb is the ONLY home use phototherapy device of its kind that has FDA 510(k) clearance for marketing, has published proof of efficacy so that NO OTHER home use laser phototherapy device on the market can make these claims, since the clearance only pertains to the HairMax LaserComb.

    The HairMax has helped hundreds of thousands of individuals around the world with hereditary hair loss who have been satisfied with the results. The return rate is less than 5% with a generous money back guarantee. Lexington also stands behind the HairMax by offering a 20 week money back guarantee (less a 20% restocking charge) if the purchaser is not satisfied with the results.

    In closing, the HairMax in clinical studies was found to regrow hair in over 90% of subjects studied, has FDA Clearance for marketing and is produced under strict quality controls. NONE of the other device purported to promote hair growth have these features and therefore their claim of "FDA Approval" are false. These are the irrefutable facts.

  10. sara says:

    what about the long term effects? the study the above article talks about was done in 2009 for a period of 26 months. Does this mean, we have NO idea what the long term effects of this may be?

  11. Sara,

    Because the above article is provided by Lexington International, a low level laser therapy manufacturer with no relation to our network or blog, I have no real way to know if there has been any follow up done on this study. I would recommend either contacting the above poster or possibly trying to email some of the researchers who worked on the project (listed above).

    Sorry I could not be of more assistance, but I cannot find any sort of follow up article either. Anecdotally, I have read the low level laser therapy is supposed to have no recorded side effects and the only real risk associated with the procedure is the potential for the laser to damage a patients eye if exposed for a long period of time.

    Blake (Future_HT_Doc)
    Editorial Assistant

  12. Once again, I am Leonard Stillman, Director of Professional Services at Lexington International. This posting is to answer comment 10 above.

    In the 10 years that the HairMax has been on the market there have been no reports of serious side effects occurring. And, there have never been any reports of adverse effects from people who have been using the device for a long period of time. The laser energy of the HairMax is not absorbed by the body, only by the hair follicles so there is no chance that there would be long term side effects.

  13. Xtreme Antler Muscle Product says:

    Howdy, I do think your site could be having web browser compatibility issues.
    Whenever I look at your blog in Safari, it looks fine however, when
    opening in I.E., it’s got some overlapping issues. I merely wanted to give you a quick heads up! Other than that, fantastic website!

  14. Bill - Managing Publisher says:

    Xtreme Antler Muscle,

    I use IE regularly and don’t see any overlapping issues. Are you using the latest version?

    I do see that your post contained a promotional link, which I suspect was the primary purpose of posting your comments. However, if you are legitimate, please provide me with more information on where you see the site overlapping and I’ll ask my webmaster to look into it.


    Bill – Managing Publisher of this Community

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