The legalities of in-home laser hair removal

In 2008, TRIA Beauty (Pleasanton, CA; formerly SpectraGenics) received FDA clearance for its TRIA Laser Hair Removal System and began marketing the device to consumers.

In 2008, TRIA Beauty (Pleasanton, CA; formerly SpectraGenics) received FDA clearance for its TRIA Laser Hair Removal System and began marketing the device to consumers. Today the company's website calls the system "the first and only FDA-cleared laser hair removal system available for at home use."

But what exactly does that claim mean?

Suited up

In late August 2009, TRIA rival Palomar Medical Technologies (Burlington, MA) issued press releases saying that the U.S. Patent and Trademark Office (USPTO) had confirmed the validity of all claims in its re-examination of the second of two patents by Palomar for optical hair removal technology. The USPTO upheld Palomar's first patent in June 2009 and affirmed 14 of the second patent's existing claims (the other eight claims were not under dispute) and two more it added for the re-examination.

Palomar is suing Syneron (Yokneam, Israel) for willful infringement of the just-affirmed patent, and both Candela (Wayland, MA) and Syneron for willful infringement of both patents (Candela and Syneron announced they would merge in September 2009). With both cases having been stayed pending the outcomes of the patent office reexaminations, Palomar said it requested that both suits start up again. And in late June 2009, Palomar also brought a patent infringement suit against TRIA Beauty, alleging it violated one of the two patents.

Joseph Caruso, Palomar's CEO, said that his company was the first to land FDA approval for a device using the technology, the first to bring a high-powered optical hair removal device to market, and the first to win FDA approval for a similar, over-the-counter device for the consumer market. However, Palomar currently offers only in-office laser hair removal products, despite attempts at non-exclusive licenses for the home-based versions.

In office vs. at home

For permanent hair reduction, Palomar offers several hair removal systems for use by dermatologists: the StarLux 500 Laser and Pulsed Light Platform working with the LuxR (650–1200 nm, 46 x 16 mm spot size, 45 J/cm2 fluence) and LuxY (525–1200 nm, 46 x 16 mm spot size, 48 J/cm2 fluence) handpieces to remove hair from large areas, with other models having smaller spot sizes and higher fluence values for small areas of the body, for people of all skin types.

Back in 2008, Palomar entered into a non-exclusive license agreement with Procter & Gamble for an at-home hair-removal system (and even received FDA approval for it in late 2006), but the system was never commercialized. Syneron currently has in-office products that use elos Technology, a combination of light energy to target the hair follicle followed by an RF (radio frequency) signal that provides maximum heating and termination of the hair follicle. Candela also offers in-office products; but to date, neither have an at-home system.

So as the patent wars continue to rage, consumers are probably more concerned with knowing just what in-home laser hair-removal products are available, and more importantly, how much they cost and whether or not they really work.

Low-cost hair loss

The TRIA Laser Hair Removal System (LHRS) is priced at $595. Mark Weckwerth, executive VP for TRIA Beauty, says the device is a little smaller than a typical hair dryer, weighing 1.36 lbs, and measuring 8 x 4.5 x 3 inches. It contains an AlGaAs (aluminum gallium arsenide) laser diode array at 810 nm and produces about 40 W with five output levels of 6, 8, 12, 16, and 22 J/cm2 with a 10 mm spot size. The class I laser reportedly will not cause retinal damage at any viewing distance. Available at TRIABeauty.com as well as on QVC, QVC.com, and at Neiman Marcus, Nordstrom, Bergdorf Goodman, STUDIO at Fred Segal, Bliss Spas, and select physician offices, the TRIA LHRS works by targeting the dark pigment in the hair. The laser and the dark pigment together generate heat that quickly disables the hair follicle, causing the hair to gradually fall out and stop growing back. Because hair grows in cycles, the TRIA Web site says individuals need one TRIA laser treatment every other week for the first 3 months, then one treatment per month for 3–5 months afterwards to achieve the best hair-free results possible (claiming you will be hair-free for good!).

Contrast $595 with the estimated "price of a small car" to complete the required salon visits according to a customer testimonial on TRIA's Web site (and according to data from hairremovaljournal.org that explains how a course of five professional laser hair removal treatments at a salon can cost between $1750 and $4250 per body area).–Gail Overton

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