HairMax LaserComb

The HairMax LaserComb is a device that claims to use to treat androgenetic alopecia in males. The developing company, Lexington International, LLC., is located in Boca Raton, Florida.
FDA clearance
The HairMax LaserComb is the only medical device cleared by the FDA for marketing for men with certain classes of pattern baldness. However, the FDA did not determine whether the LaserComb is safe or effective. Instead, it determined that the device is similar to devices sold before 1976, and could therefore be legally marketed without proof of safety or effectiveness, under rule 501(k)..
Controversy
A number of devices are sold that use low level laser energy directly on the scalp with the intent to stimulate hair growth through "Photo-Biostimulation" of the hair follicles. One product of these low level laser therapies is the Hairmax Lasercomb which is the only laser phototherapy device to receive FDA clearance for marketing. A clinical study on the effects of HairMax LaserComb that was submitted to the FDA and has recently been published in a peer-reviewed journal claims clinical efficacy of the LaserComb when compared to a sham-device used as a control. The study's four authors include David Michaels, Co-founder and Managing Director of Lexington International, manufacturer and developer of the HairMax LaserComb , as well as owner of the domains "hairmax.com," "hairmaxforum.com," and "lasercomb.net" ; Matt Leavitt, medical advisor and official spokesperson of Lexington International, manufacturer and developer of the HairMax LaserComb ; Glenn Charles, owner of a private hair transplantation and restoration practice in Boca Raton in Florida, seat of Lexington International, the manufacturer and developer of the HairMax LaserComb ; and Eugene Heyman, a biostatistician from Montgomery Village in Maryland who offers paid services to companies seeking FDA approval for medical devices and pharmaceutical products . The HairMax LaserComb is thus the only laser phototherapy device to date on which results of a clinical study have been published in a peer-reviewed journal.
The HairMax LaserComb was cleared for marketing in 2007 based on the submission of an FDA Premarket Notification 510(k)- K060305. Because similar devices were marketed before 1976, this application for FDA clearance allows the LaserComb to be marketed without proving its effectiveness. Lexington International also submitted clinical data showing efficacy, according to the company. There is controversy over the FDA Premarket Notification 510(k) process which has been called superficial in some quarters. In a letter to the N.Y. Times newspaper, the Director of the Center for Devices and Radiological Health, FDA responded to this allegation as follows: “……….under the congressionally established 510(k) process, the FDA often reviews laboratory and clinical data to substantiate the medical claims for a new device, based on the product’s nature and potential risk. The data are then reviewed by experts within, and sometimes outside, the FDA. The 510(k) process is an important tool for ensuring that devices entering the market do not raise new questions regarding safety or effectiveness”
FDA Warning Letter
In May 2008 US Regulators at the FDA issued Lexington a Warning Letter citing that the HairMax LaserComb Premium and SE models, that are currently being sold to the public, differ from the cleared HairMax LaserComb in dose rate, method of delivery, and/or treatment parameters. According to the FDA these changes could significantly affect the safety or effectiveness of these devices and therefore, pursuant to 21, CFR 807.81 (a)(3)(i), new 510(k) submissions are required in order to legally market these devices. Lexington responded to the issues contained in the Warning Letter by 1) removing the HairMax LaserComb S/E model from sale in the US and 2)discontinued manufacturing the new design and returned to market the original design that was give 510(k) clearance for marketing by the FDA.FDA Warning Letter

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