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HairMax FDA Clerance for the Treatment of Hair Loss
6 FDA clearances for both MEN & WOMEN, no other medical devices come with this kind of assurance by the US FDA for the treatment of hair loss and thinning hair. No drugs, no surgery, no pills, no medications, no costly maintenance routines.
This is impressive by any standards in the medical and hair loss community.
As of to date, HairMax has received an unprecedented total of 6 FDA Clearances for marketing since 2007 . As with any other FDA protocols, all clearance processes were subject to intense scrutiny and review by the government on many levels. When a company receives this clearance, there are stringent rules and high standards put into place covering all aspects of manufacturing and quality control. The HairMax LaserComb is the only Laser PhotoTherapy device that has been reviewed by the FDA and cleared for marketing four times for the treatment of androgenetic alopecia (pattern hair loss) in both males and females*. Clinical data was submitted to the FDA and rigorously reviewed for all 510(k) submissions.
In June 2011, HairMax received FDA Clearance for the treatment of hair loss in females with androgenetic alopecia (pattern hair loss*).
In January 2007, the HairMax LaserComb® became the first and only medical laser device for home use to receive FDA Clearance for the treatment of hair loss in males with androgenetic alopecia (pattern baldness).*
In 2010, Lexington Int’l completed its six-month, multi-center device controlled clinical trials for the treatment of (androgenetic alopecia)female pattern hair loss and submitted data to the FDA. The data from the trial indicated that 100% of participants, all 25-60, experienced hair growth. Further, subject assessment of thickness and fullness of hair was statistically significant for the HairMax over the control device. No serious side effects were reported
In June 2011 the FDA granted marketing Clearance for the HairMax for the treatment of androgenetic alopecia (female pattern hair loss)* based in part on the results of the 2010 clinical studies.
In August 2011, the FDA granted marketing Clearance for the HairMax Dual 12 device and for 3 new HairMax models, the HairMax Professional 12, HairMax Lux 9 and HairMax Advanced 7.
After years of extensive research and randomized clinical studies, Lexington International submitted the results of its initial six-month, multi-center placebo controlled clinical trials to the FDA. The data from the trials indicated that 93% of the participants had a medically significant increase in hair growth. No serious side effects were reported. Based on part of the results of this study, the FDA granted initial marketing for the treatment of androgenetic alopecia, (pattern hair loss)* in males.
All of the clinical trials conducted since 2006 have provided conclusive evidence that the HairMax is consistently effective and safe for the treatment of male and female pattern hair loss*. The HairMax is a viable treatment option for those wishing not to use drugs and/or topicals.
The results of the key clinical study in 2006 which led to the original FDA clearance was published in the May 2009 Issue of Clinical Drug Investigation. The article entitled, HairMax LaserComb Phototherapy Device in the Treatment of Male Androgenetic Alopecia, is indexed as Clin Drug Invest 2009: 29 (5): 283-292 in most of the biomedical databases such as MEDLINE, EMBASE/Excerpta Medica, etc. The studies also showed that there were no serious adverse effects in any of the trial participants.
*The HairMax Advanced 7, Lux 9, and the Professional 12 models are indicated to treat Androgenetic Alopecia, and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V and in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss and who both have Fitzpatrick Skin Types I to IV.