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HairMax LaserComb is the only at-home FDA Cleared medical device to treat hair loss and promote hair growth in men and women. Results can be achieved in as little as twelve weeks.
We are proud to introduce the NEW HairMax LaserComb, including Premium 9 and Lux 9 models with 9 laser beams, and professional 12 with 12 laser beams, which now incorporates an updated, modern, and innovative design with a rechargeable lithium ion battery.
The new HairMax Laser Comb utilizes the same laser diode system as the original HairMax Premium. It has a user-friendly, sleeker look, and most importantly incorporates a cordless option that allows you to use the device anywhere. You can now simply store your HairMax in the charging station provided when not in use and the device will be ready to exert its positive effects at any time, anywhere.
FDA Approves HairMax LaserComb to Treat Baldness
HairMax LaserComb FDA Clearance is a Milestone in Hair Care, Hair Growth and Hair Science
1. HairMax LaserComb is the first and only medical laser device to receive FDA Clearance to market for the "Promotion of Hair Growth" in males with hereditary hair loss was based primarily on proof of EFFICACY.
WASHINGTON Feb 15, 2007 (AP) Drawing this special comb over a balding pate could restore some real hair according to a Florida company. The Food and Drug Administration has cleared for sale a handheld laser device to promote hair growth.
Called the Hairmax Lasercomb, it increases the numbers of thick hairs on the scalp, according to 26-week clinical trials conducted by its manufacturer, Lexington International LLC.
As the device's name suggests, it combines a low-level laser with a comb. When drawn through the hair, the laser strikes the scalp to promote hair growth, according to the company.
The device, sold on the Web for US$545, is the only drug-free product meant for home use in combating hair loss that's won the endorsement of the FDA, the company said.
(The model shown on the picture is HairMax Laser Comb, Premium.)
2. FDA Clears HairMax Laser Comb to Treat Female Pattern Hair Loss and Promote Hair Growth - NEW
Boca Raton, FL (June 15, 2011) - For the first time in twenty three years, a new home-use treatment for female hair loss is available. Lexington Intl, LLC, is excited to announce they have received groundbreaking FDA Marketing Clearance for the HairMax LaserComb Lux 9 to treat female hair loss and promote hair growth.
"Hair loss amongst women is a growing concern", says Dr. Matt Leavitt, "In the past, women had only one FDA Approved drug ingredient to treat their hair loss. Now they have a clinically proven viable alternative. Upon review of Lexington's extensive clinical studies on female hair loss, the FDA has granted Clearance to this exciting new treatment option. I believe the HairMax will be able to offer help to the millions of women suffering from hair loss."
The last hair loss treatment for women to be approved by the FDA was minoxidil, which came to market for females in 1988. The HairMax is now the first non-drug, home-use OTC medical device cleared to treat the estimated 80 million men and women suffering from hereditary hair loss.
The HairMax Lux 9 is indicated to treat Androgenic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-4, II-1, II-2 or frontal and Fitzpatrick Skin Types I-IV.
1. Aug. 26, 2010 - HairMax LaserComb was reviewed on THE DOCTORS TV show again this week. Hair restoration expert Dr. Craig L. Ziering explains the HairMax LaserComb can help reduce hair loss and encourage re-growth.
2. LEXINGTON IS PROUD TO INTRODUCE OUR NEW HAIRMAX LASERCOMB MODELS
November 2009 - The original HairMax LaserComb Premium has been a great product. The laser therapy provided from the HairMax has helped hundreds of thousands of men and women suffering from hair loss. Now, we have taken our clinically proven technology and have incorporated it into a new sleek ergonomic design. And it is battery powered. Now you have the freedom of movement as you treat your hair with the new HairMax devices. Lexington took special care to ensure the new device will be just as effective as the original model. The battery circuitry has been designed to ensure that the laser energy will remain constant throughout the treatment cycle. If the battery weakens, the laser will shut off (not diminish) and alert the user that it is time to plug in or charge the batteries. Our new product family will consist of the following three devices.
HairMax LaserComb Professional 12 - Featuring a sleek design, 12 laser diodes, a rechargeable lithium ion battery, vibrate mode and LCD display. Designed for the professional hair clinics and doctors.
HairMax LaserComb Lux 9 - Featuring a sleek design, 9 laser diodes, a rechargeable lithium ion battery, vibrate mode and LCD display. New Lux9 utilizes the same laser diode system as the original HairMax Premium.
HairMax LaserComb Advanced 7 - Featuring 7 laser diodes, replaceable AA alkaline batteries.
3. FDA CLEARS THE HAIRMAX LASERCOMB FOR THE PROMOTION OF HAIR GROWTH
February 2007 Lexington International LLC is proud to announce the landmark achievement of US Food & Drug Administration (FDA) clearance for their medical laser device, the HairMax LaserComb. Through years of extensive research and clinical studies in the science of hair growth, Lexington has developed an affordable and convenient, hand-held laser device, now clinically proven to promote hair growth in males with androgenetic alopecia (Norwood IIA to V with Fitzpatrick skin types I to IV).
This FDA clearance of the HairMax LaserComb offers an exciting new modality for the promotion of hair growth in males. Until now, the FDA has only approved two other products as solutions to combat hair loss, a condition that affects approximately 55 million men in the U.S. But the HairMax LaserComb stands out as the only proven drug-free alternative. This gives many hair loss sufferers, previously unable or unwilling to turn to drug-based solutions, newfound hope in their battle. Fortunately, treatments using the HairMax LaserComb are easy to administer, only 10 to 15 minutes three times per week, and the laser device is convenient to use in the comfort and privacy of your own home.
For the FDA submission, Lexington conducted an extensive clinical study in four different locations across the United States. The study concluded that 93% of the participants (ages 30-60) using the HairMax LaserComb had an increase in the number of terminal (thick) hairs. The average number of terminal hairs per square centimeter increased by 19 hairs/cm² over a six-month period. During the study, there were no reports of serious adverse events. The number and types of adverse events were similar in both the active and placebo groups.
Lexington's clinical study investigating the efficacy of the HairMax LaserComb in females is concluding and they will be submitting the data to the FDA shortly.