Lasercomb
| Lasercomb at a glance | |
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The good: Unlikely to have any side effects. The bad: Expensive, no peer reviewed studies to show effectiveness. Bottom Line: Don't bother unless you've got money and time to burn.
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Hairmax Lasercomb is a commercially marketed device with claimed growth stimulant properties. The device uses laser light (655 nm) applied topically to the scalp as the user moves the unit over his head.
The Lasercomb is marketed and developed by Lexington International, LLC, a Boca Raton, Florida based company. It has received considerable attention from various media outlets. [1]
The Lasercomb is operated by placing the device at your hairline and moving it back in ½ inch steps each four seconds, or when the device beeps. The recommended amount of usage is 3 times per week, at 15 minutes per treatment. [2]
Two versions are currently being sold:
- Lasercomb Premium at $545USD with 9 laser lights.
- Lasercomb SE at $395USD with 5 laser lights.
A low level laser is shone directly on the scalp to stimulate hair growth through "Photo-Biostimulation" of the hair follicles.
[edit] Controversy
Much has been made of the "FDA Approval" terminology used in reference. The Lasercomb has received a 510(k) pre-market notification from the FDA:
- Section 510(k) of the Food, Drug and Cosmetic Act requires those device manufacturers who must register to notify FDA, at least 90 days in advance, of their intent to market a medical device. This is known as Premarket Notification - also called PMN or 510(k) . It allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. [3]
This acknowledges the following:
1. That the FDA found satisfaction in the submitted study, which in this case, says the device is "safe and effective as an aid in hair regrowth in males".
Most importantly, the FDA has accepted the study data with all claims therein. [4] The makers of Lasercomb are not allowed to say "FDA approved", but a device like the Lasercomb cannot reach the same level of approval a drug like Finasteride could.
2. That the device appears safe and equally effective to existing products in the same class [4].
The Lasercomb was found to be Substantially Equivalent (SE) to predicate devices legally marketed before May 28, 1978. This includes a variety of laser based, non-hair growth devices intended for hair removal and pain relief, and three unapproved non-laser based hair growth devices: Dr. Scott's Raydo and Wonder Brushes, and Evan's Vacuum Cap. [5] These last three devices are now accepted as quackery.
The 501(k) itself has come under fire for some other questionable modern products.
The Lasercomb is classified by the FDA as a "Physical Medicine Therapeutic Device", which in this case is [6]:
- An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.
Furthermore, no studies have been submitted to peer reviewed journals at this time. The internal study that was used to submit for approval to the FDA has not been peer reviewed, and as such should be taken with a grain of salt.
[edit] Side Effects
Probably none.
[edit] See also
- Instructional forum post on building your own Lasercomb-like device
- Search for "Lasercomb" at: HairLossTalk.com, HairLossHelp.com, Hairsite.com
[edit] References
- ↑ Lasercomb: In the news
- ↑ LaserComb: How do I use the LaserComb?
- ↑ Information on Releasable 510(k)s
- ↑ 4.0 4.1 Google cache of www.fda.gov/cdrh/pdf6/K060305.pdf
- ↑ Baldness: A Social History - Google Book Search
- ↑ FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H--MEDICAL DEVICES