The Family Of HairMax Laser Combs
Choose From 3 Different Models
ColdLasers.Org no longer sells this product due to negative customer feedback. We sell only therapeutic lasers. Even though many therapeutic lasers are the correct wavelength (650nm range), they will not produce consistent results.
The HairMax LaserComb is the first and only home use laser device FDA cleared and clinically proven to promote hair growth. All HairMax products feature:
- Clinically Proven Efficacy
- Visiable Results in 16 weeks
- 93% of Clinical Study Group Experienced Hair Growth
- Recommended by Leading Physicians
- Low cost when compared to surgery and other forms of growing more hair
- Continuous Class II Cold Laser
The HairMax LaserComb was originally released in 2000 and acclaimed as "The Invention of the Year" by Time Magazine. Since then the HairMax products have received acclaim by such notable celebrities as Dr. Oz, Rachel Ray and Dateline (click on the images below to see videos).
The Science of Cold Laser Therapy and the HairMax LaserComb
Through the scientific principle of "Photo-Bio Stimulation", the HairMax LaserComb stimulates hair follicles
to grow thicker, healthier and fuller hair." Light is energy. Living cells thrive in light and hair follicles benefit from the light energy provided by the HairMax LaserComb. Lexington has been developing laser therapy since the 1980?s. Through extensive clinical research, Lexington has determined the exact wavelength and energy level that is most beneficial in stimulating weakened hair follicles. In recent clinical studies, the HairMax grew an average of 21.6 hairs per centimeter(2) in males and 20.2 hair per centimeter(2) in females. This is scientifically and medically significant and a true milestone in the treatment of hair loss in men and women.*
Laser energy has been demonstrated to increase the blood flow circulation in the hair follicles of the scalp which is crucial to promoting a healthy hair follicle. The laser energy of the HairMax energizes the hair follicles in what we believe is a two-fold approach:
- Increased vascularization resulting in increased blood flow
- An increase in cellular metabolism
The increase in blood flow brings the important nutrients into the follicle, while taking away harmful waste products such as DHT. Additionally, it is hypothesized that low level laser energy is absorbed into the mitochondria of the cell which helps to increase the production of the metabolic energy transponder known as adenosine triphosphate (ATP). The increase in ATP promotes cellular metabolism and cellular activity. This enables the hair follicle to have the building blocks to return to a healthy state due to both increased blood flow and the energy from the increase in ATP to transform the weakened hair follicle to one that is healthy and capable of producing a thick mature hair.
The data compiled from this trial indicated that 93% of participants had a medically significant increase in hair growth*. The results of the clinical study which were a key part of the FDA 510(k) submission
and subsequent Clearance for marketing in 2007. Results of this clinical trial were published in the May 2009 issue of the peer review journal Clinical Drug Investigation+.
Since 2001, Lexington has completed a total of se en clinical studies
with 460 subjects. Over 93% of clinical study participants using
the HairMax experienced hair growth. All the results of these studies have demonstrated the efficacy and safety of the HairMax LaserComb. The statistically significant clinical results from these studies validate the fact that the HairMax should be considered as a first line treatment for appropriate men and women suffering from hair loss*.
Clinical Trial Proves Efficacy in Males and Females
In 2009-2010, three multi-center, double-blind device controlled clinical studies were conducted throughout
the United States under Good Clinical Practices Guidelines (GCP). Further, Institutional Review Board (IRB) Clearance was obtained from Chesapeake IRB and the studies were monitored by Palm Beach CRO. The principal investigators for the studies were Zoe Draelos, M.D., Janet Hickman, M.D., David Goldberg, M.D., Michael Jarratt, M.D., Jose Mendez, D.O. and Abe Marcadis, M.D. All participants in the studies were males and females, 25-60 years of age, diagnosed with Androgenetic Alopecia (male pattern baldness and female pattern hair loss respectively). Subjects in each study were divided into two groups: one group used the HairMax LaserComb® and the other group used a non-laser control device. The trails were listed on www.clinicaltrials.gov, a registry of federally and privately supported clinical trials conducted in the United States and around the world.
Trial subjects performed treatments three times a week on non-consecutive days for a period of 26 weeks. Hair growth was evaluated using a photographic technique called macrophotography to enable hair
counting. At 16 and 26 weeks, the number of thick, healthy, pigmented (terminal) hairs in a target area were compared to the beginning (baseline) hair counts.
The results of these studies in males showed that the average number of terminal hairs per centimeter squared (hair count)
increased by 21.6 hairs at the completion of the study (26 weeks) vs. 6.4 hairs for the control device.
In the female study the average number of terminal hairs increased by 20.2 hairs at the completion of the study (26 weeks) vs. 2.8 hairs for the control device. These results are scientifically and medically significant. It is important to realize that these hair count are averages, and that some males and females experienced hair count increases greater than 50 and 40 hairs per centimeter squared respectively.
Data from these clinical studies, showed that over 93% of all male subjects and 95% of all female subjects experienced hair growth over the course of the study. Further, no subject in any study experienced
serious side effects.
These data were submitted to the FDA as part of two 510(k)
filings in 2010. The first filing was for the treatment of androgenetic
alopecia in males for three new models of the HairMax. The second was for the treatment of androgenetic alopecia in females. In April 2011, the FDA granted Class 2 Clearance for marketing of three new models of the HairMax LaserComb (see page 10 for description of the new models). Most importantly in May 2011, the FDA granted
Clearance for the treatment of Androgenetic Alopecia and to
promote hair growth in females.
The images below are representative of a successful user experience by subjects in our clinical studies. It is clearly evident that both male and female users alike can benefit from continued use of the HairMax LaserComb.
Before Using the HairMax LaserComb
After the HairMax LaserComb (26 Weeks)
To date, the HairMax has been featured for sale by the most well-known online retailers, direct response catalog companies and television sales organizations. Furthermore, hair restoration clinics, transplant physicians, cosmetic surgeons, dermatologists, and salons offer the HairMax LaserComb to their customers.
They see the value in a drug-free treatment alternative that delivers on its promise - to achieve meaningful results.
* Under the FDA clearance, 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 Fitzpatrick Skin Types I to IV 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.