Why Doesn’t FDA Do Something About Hairmax?
If that’s the case then why doesn’t FDA do something about hairmax openly claiming that their device was tested by FDA for EFFICACY and safety? FDA did mind when hairmax stated that their device was APPROVED instead of cleared. So why dont they mind now? Such devices cannot be approved but only cleared.
Why dont you put this subject to rest by contacting FDA and asking them if they tested efficacy as well?
What about the recent peer reviewed published materials in the scientific journals that you were asking for so badly a couple of years ago?
What about your laser hat trials??
I respect you very much doctor, but when you talk about LLLT, you seem to be against it without any substantial basis.
Our laser cap trials were inconclusive with mixed results. The subjective view of some patients suggested benefit, but when we measured the hair bulk on these patients we saw not benefit. Patients had mixed reviews. One can argue that the trials were inherently flawed because we gave the laser caps away as a compensation for their time.
It is not my job to contact the FDA and my opinion of laser light therapy for hair growth is just that: my opinion. If you disagree with my opinions here on BaldingBlog, then I am ok with that! I want to correct one of your statements: The FDA does not, nor does it ever, test these devices. They rely on the manufacturer for the tests and review their data in submitted applications.
I am Leonard Stillman, Director of Professional Services at Lexington International, LLC, manufacturers of the HairMax LaserComb. This post is NOT for commercial purposes, but is to notify your readers of 2 landmark clinical papers that were published in April 2014, both authored by leaders in the treatment of hair disorders. They were peer-reviewed.
The first one appeared in the peer-review medical journal, The American Journal of Clinical Dermatology in April 2014. The article provides complete information on 4 studies with 225 subjects, which conclusively proved the efficacy and safety of the HairMax LaserComb in treating male and female pattern hair loss.
This article is entitled:
Efficacy and Safety of a Low-level Laser Device in the Treatment of Male and Female Pattern Hair Loss: A Multicenter, Randomized, Sham Device-controlled, Double-blind Study
(Am J Clin Dermatol. 2014 Apr;15(2):115-27)
These were the results found in this study: “In four randomized, double-blind, sham-controlled trials of male and female pattern hair loss, we detected a statistically significant increase in terminal hair density after 26 weeks of lasercomb treatment compared with sham treatment.”
Below is a link to the complete article:
https://link.springer.com/article/10.1007/s40257-013-0060-6
The second one appeared in the peer-review medical journal, The International Journal of Trichology in August 2014. The article provides photographic evidence of the efficacy of the HairMax LaserComb used on subjects treated for at least 9 months for drugs and were either no longer responding or were intolerant of these treatments. The HairMax LaserComb was added to treatments with either with minoxidil and/or finasteride regimens, or used in place of these treatment. Almost 90% of patients treated with drugs and the HairMax LaserComb had significant results, and 100% of those patients treated with the device in place of the drugs, showed significant results.
This article is entitled:
Use of Low-Level Laser Therapy as Monotherapy or Concomitant Therapy for Male and Female Androgenetic Alopecia
(Int J Trichology. 2014 Apr;6(2):45-9)
Below is a link to this study:
https://www.ijtrichology.com/article.asp?issn=0974-7753;year=2014;volume=6;issue=2;spage=45;epage=49;aulast=Munck
These 2 articles provide conclusive proof of the efficacy and safety of the HairMax LaserComb for the treatment of certain classes of hereditary hair loss in both men and women.
We invite your readers to visit our web site, http://www.hairmax.com, to see if the HairMax LaserComb is right for them.