Comments on: A laser alternative to the comb-over

High-tech hair device has FDA approval

[msquared.id.au]

FDA approval doesn't mean it works

Just remember that FDA approval is not an endorsement of the product or proof of its ability to do what it claims, but only that it's very unlikely to injure someone during normal usage.

[moretroops]

Good news for the follically challenged.

Did I spell that right? Anyway, the fact that this received FDA approval is
suprising. Contrary to the first poster, approval doesn't simply mean the
product isn't harmful. Otherwise all those BS herbal remedies would get
approval -- but they don't, which is why GNC doesn't sell prescription meds, but
rather cheap soy protein and quack pills. But I digress. FDA approval means
that a drug or other treatments has been proven safe AND effective. That's why
it's so hard to get. So, studies must show that this laser thing works, at least
somewhat.

[lexington_international]

The key results of the pivotal clinical study were published this month in a peerreviewed journal which demonstrated conclusively that the HairMax is effective for certain classes of male pattern baldness. This clinical study was a key factor in the FDA 510(k) clearance for marketing decision for the HairMax LaserComb. Below is the abstract of this study from Medline:

1: Clin Drug Investig. 2009;29(5):283-92. doi: 10.2165/00044011-200929050-00001.Links
HairMax LaserComb(R) Laser Phototherapy Device in the Treatment of Male Androgenetic Alopecia: A Randomized, Double-Blind, Sham Device-Controlled, Multicentre Trial.Leavitt M, Charles G, Heyman E, Michaels D.
Private Dermatology Practice, Maitland, Florida, USA.

The use of low levels of visible or near infrared light for reducing pain, inflammation and oedema, promoting healing of wounds, deeper tissue and nerves, and preventing tissue damage has been known for almost 40 years since the invention of lasers. The HairMax LaserComb(R) is a hand-held Class 3R lower level laser therapy device that contains a single laser module that emulates 9 beams at a wavelength of 655 nm (+/-5%). The device uses a technique of parting the user's hair by combs that are attached to the device. This improves delivery of distributed laser light to the scalp. The combs are designed so that each of the teeth on the combs aligns with a laser beam. By aligning the teeth with the laser beams, the hair can be parted and the laser energy delivered to the scalp of the user without obstruction by the individual hairs on the scalp. The primary aim of the study was to assess the safety and effectiveness of the HairMax LaserComb(R) laser phototherapy device in the promotion of hair growth and in the cessation of hair loss in males diagnosed with androgenetic alopecia (AGA). This double-blind, sham device-controlled, multicentre, 26-week trial randomized male patients with Norwood-Hamilton classes IIa-V AGA to treatment with the HairMax LaserComb(R) or the sham device (2 : 1). The sham device used in the study was identical to the active device except that the laser light was replaced by a non-active incandescent light source. Of the 110 patients who completed the study, subjects in the HairMax LaserComb(R) treatment group exhibited a significantly greater increase in mean terminal hair density than subjects in the sham device group (p < 0.0001). Consistent with this evidence for primary effectiveness, significant improvements in overall hair regrowth were demonstrated in terms of patients' subjective assessment (p < 0.015) at 26 weeks over baseline. The HairMax LaserComb(R) was well tolerated with no serious adverse events reported and no statistical difference in adverse effects between the study groups. The results of this study suggest that the HairMax LaserComb(R) is an effective, well tolerated and safe laser phototherapy device for the treatment of AGA in males.

PMID: 19366270 [PubMed - in process]

Also, as far as the 510(k) clearance process there is a reference to this process at the HairMax LaserComb web site:
http://www.hairmax.com/ClinicalResearch/HairMaxFDA510kMedicalDeviceClearance.aspx
and this will fully explain about these types of submissions