|
|
|
Financing Insurance Workplace Legal issues Name choice Name change Driver’s license Birth certificate Passport Marriage Will Other documents
|
Go to hairfacts.com for the latest commercial-free consumer hair removal information. StarLight/LightSheer page: http://www.hairfacts.com/makers/laser/coherent.html Return to TS Road Map hair removal index Return to TS Road Map Home StarLight diode laser: Facts for consumers LightSheer is the brand name for Star Medical's StarLight Pulsed Diode Array Laser System. For those trying to keep score, here's the hierarchy within this corporation: Star Medical is a division of Palomar, which is a division of Coherent, the mother of all laser companies. Anderson conducted the clinical data for ruby laser EpiLight's 510(k), and apparently LightSheer's too. LightSheer has been cleared to market under the same conditions as SoftLight and subsequent lasers. To quote the FDA official who signed the 510(k) clearance: "The StarLight Pulsed Diode Array Laser System is intended to remove hair." That's it. No mention of how long it will last. That means FDA has restricted LightSheer from using the terms "painless," "permanent," or even "long-term" to describe their results. I have not seen any clinical data on LightSheer. On their 510(k), LightSheer claims they checked clinical results for only 9 months, and report only "significant hair loss and prolonged growth delay."For some, that's great. Vague, but great. However, that ain't permanent. I have respect for Coherent's general integrity, but their new acquisition Palomar (Star Medical's parent company) has had some very questionable business practices in the past, and I have serious ethical concerns about their marketing efforts. In addition, Dr. Rox Anderson's financial connections to Palomar and the amount of money he stands to make give me reason to scrutinize his rosy clinical results very carefully. I'll be happy to elaborate on all this if you'd like. I'll see if I can rustle up Anderson's LightSheer clinical data soon. If you look at Coherent's site, you'll see no LightSheer clinical data, but you will see what's most important to those who buy LightSheer machines: The doctors who use EpiLaser or LightSheer can expect "a six-figure increase in additional net income." Ch-Ching! A graph shows a range of $150,000 to $500,000 *annually*. And the best part, as they say: "All collect directly from patients." Obviously, many patients out there are shelling out some major out-of-pocket change for unproven hair removal. Never mind if it's permanent, doc-- you'll be rich! Those who gambled on SoftLight's hype found out the hard way SoftLight was woefully inadequate. Until there's definitive clinical data, trying LightSheer, EpiLight, or any of the lasers is still a big gamble, if permanence is your goal. In the meantime, those who can't afford to risk their time, money, or complexion on unproven hair removal device should invest in the only proven permanent option: electrolysis. FDA 510(k)
Thanks to Elizabeth for sending along the following ASDS info: Study results presented at the 25th Annual Scientific and Clinical Meeting of the American Society for Dermatologic Surgery in May 1998 suggest that the new diode laser "safely produces long-lasting hair removal," according to a press release. They do not define "long-lasting," the term over which ThermoLase was sued and settled out of court a few months later. Melanie C. Grossman, MD, reviewed clinical data using an 800 nm diode laser on 100 patients with skin types I-VI, light to very dark skin. Dr. Grossman is a clinical assistant professor at Cornell University and the New York Hospital in New York City. She also appears in about every other fashion magazine touting lasers. The diode laser contains several small diodes or semiconductors that are arranged together to produce light. A diode laser is significantly smaller than traditional lasers, so some laser salespeople consider it a convenient and portable system for in-office procedures. In the clinical study, each subject had seven test areas, five of which received a single laser treatment, and two that received an additional treatment after one month. Fluence and pulse duration varied. There was one control site. Treatment of a larger area was also performed on each patient. Patients were evaluated 1, 3, 6 and 9 months after treatment. Of course, 9 months is far too short a time to make an accurate assessment of results in terms of permanance. Hair regrowth was assessed subjectively and objectively by computer images with a CCD camera (charged coupled device that produces digital images). Everyone had at least some hair removal that lasted three months, but they don't elaborate on the relatively poor later results. Temporary skin discoloration was seen in less than 10% of the subjects, and there was an absence of scarring. This is better than early ruby tests. |
|
|
|
||
