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A handheld laser device designed to treat hair loss has been approved by the U.S. Food and Drug Administration.
The Florida company that makes the Hairmax Lasercomb said 26-week trials found that the device does increase the numbers of thick hairs on the scalp, the Associated Press reported.
Lexington International LLC said its device combines a low-level laser with a comb. When it's drawn through the hair, the laser affects the scalp in way that promotes hair growth.
According to the company, the Hairmax Lasercomb is the only FDA-approved drug-free product for home use in fighting hair loss. The device sells for $54 on the Web, the AP reported.
HealthDay News, February 16, 2007
IRIDEX Corporation completed its acquisition of the esthetics business of Laserscope.
By Rick Krupnick
Learn how offering LED therapy treatments can boost your spa’s revenue stream and increase your clientele.
When it comes to treating the aging face, patients have their pick of numerous laser therapies for successful skin rejuvenation. But finding an effective treatment for the delicate skin of the neck can often be a real pain in the neck. Now, a retrospective review presented in a recent issue of Lasers in Surgery and Medicine, the journal of the American Society for Laser Medicine and Surgery, finds that a skilled practitioner can successfully resurface an aging and photodamaged neck using the Carbon Dioxide (CO2) laser if a series of treatment parameters are strictly followed.
In her article entitled “Safe and Effective Carbon Dioxide Laser Skin Resurfacing of the Neck,” laser expert Suzanne D. Kilmer, MD, of the Laser & Skin Surgery Center of Northern California, Sacramento, CA, outlines three key components essential to effective laser resurfacing of the neck with the CO2 laser that she and her colleagues have used to safely treat more than 1,000 patients over the past 10 years.
“We have found that for the CO2 laser to work safely and effectively on the neck, 1) the skin has to be sufficiently hydrated with a pre-operative topical anesthesia; 2) the laser has to be administered at a low density with only a single pass; and 3) the treated epidermis must not be wiped following the procedure,” explains Dr. Kilmer. “These three ingredients, in a sense, make up the ‘recipe’ for how to safely use the CO2 laser for neck resurfacing. And like all recipes, every step must be followed and all the ingredients must be added properly for the end result to turn out right.”
In order to adequately hydrate the skin prior to the laser procedure, Dr. Kilmer recommends that patients wash their entire face and neck with hot water and then immediately apply a thick layer—like frosting on a cake—of the topical anesthesia EMLA. The area is then sealed using a plastic wrap, and this process is repeated 45 minutes before the procedure. Dr. Kilmer notes that proper hydration is critical, as it “plumps up” the skin and creates a protective buffer against the laser that also aids in absorbing the laser’s energy.
During a typical laser skin resurfacing of the face with the CO2 laser, the epidermis is completely removed. For neck resurfacing, the laser energy is lowered so the epidermis is not removed and stays intact. This low density coupled with a single pass of the laser creates less trauma and less wounding on the neck. Dr. Kilmer points out that while the face would normally be wiped to remove the epidermal debris following the procedure, it is important not to wipe the treated epidermis from the neck because it serves as a natural dressing that protects the skin and aids in the healing process.
“Most of our patients that undergo CO2 laser skin resurfacing on their face also get their neck done at the same time,” says Dr. Kilmer. “Performing both procedures helps to blend the results, eliminating the noticeable line of demarcation that usually occurs when the neck is left untreated.”
While non-ablative laser treatment for skin rejuvenation has gained in popularity during the past few years, Dr. Kilmer notes that the CO2 laser produces longer-lasting results than its non-invasive counterparts and only a single treatment session is needed instead of a series of treatment sessions.
“As with any procedure, patients need to be informed of the potential risks, how much downtime is involved, and the importance of post-operative care before undergoing CO2 laser resurfacing,” adds Dr. Kilmer. “But for any single resurfacing treatment, the CO2 laser delivers the most overall improvement—hands down.”
Patients with a personal or immediate family history of vitiligo are not considered candidates for this procedure, as laser resurfacing can trigger depigmentation of the treated area consistent with this condition.
The Food and Drug Administration yesterday outlined a plan for tougher monitoring of the safety of medical devices once the products are on the market. It comes just after Democrats , who promise more aggressive oversight of the FDA, wrested control from Republicans in the House of Representatives and Senate.
The FDA said the timing of yesterday's plan was "totally unrelated" to the election outcome. The agency's plan includes an electronic system for reporting serious side effects, to replace the paper reports now filed by medical professionals and patients.
"The entire FDA post-marketing surveillance system is weak both for drugs and devices," said Dr. Steve Nissen , a Cleveland Clinic Foundation cardiologist scheduled to testify at a congressional hearing this month about the FDA. "Unfortunately, adverse event reporting is voluntary and, generally, only 1 to 10 percent of events are reported," Nissen said.
A Democratic-led Congress appears willing to make that and other FDA improvements, starting by shuffling a few key committee chairmen.
Democrats Edward M. Kennedy of Massachusetts , Henry A. Waxman of California , and Bart Stupak and John D. Dingell both of Michigan are poised to head key congressional panels with investigatory powers and FDA oversight.
"With congressional oversight, [the FDA is] going to face a much tougher, much tougher environment," said John Manthei , a partner in the Washington, D.C., office of Latham and Watkins LLP . "Mr. Waxman and Mr. Dingell and Mr. Stupak have made it very clear that FDA is squarely within their crosshairs," said Manthei, FDA counsel for the Medical Device Manufacturers Association .
Kennedy has co sponsored reform legislation that, among other changes, shifts planning for how to handle emerging drug risks to the preapproval phase—when the FDA has more clout—and provides more drug-safety funding.
The FDA said that its plan will help it better detect and take action on risks related to thousands of medical devices, such as mesh stents used to prop open clogged arteries, pacemakers, and implantable defibrillators that tame irregular heart beats.
The agency is under fire for underestimating such problems as long-term heart risks attributed to drug-eluting stents, manufactured by companies that include Natick's Boston Scientific Corp . The FDA relied on short-term studies for the approvals. Next month , it will convene an advisory panel to discuss cardiovascular safety data from longer-term use.
In addition to the electronic reporting system for side effects, the FDA already has assembled a network of 350 hospitals that report problems with devices, shortening the time it takes for the agency to learn about problems. Dr. Daniel Schultz , director of the FDA's Center for Devices and Radiological Health , said the agency will more aggressively tap that database.
In addition, medical devices soon could carry "unique identifiers" that make it easier to track them down, permitting more focused recalls of problematic models.
By Diedtra Henderson, Boston Globe Staff, November 10, 2006
The Board of Laser Safety (BLS)/The National Council on Laser Excellence (NCLE) now offer a collaborative, unified Certified Medical Laser Safety Officer program (CMLSO) to promote overall acceptance of laser certifications. To contact the BLS, call 407-380-1553. For the NCLE, call 614-883-1739.
The California Senate has introduced Senate Bill 1423, which will restrict registered nurses, physician assistants and physicians who have esthetic practices from using laser and IPL systems. In addition, Massachusetts, Georgia and North Carolina are considering similar bills.
By: Craig Wenborg, MD
Learn about this new trend in skin care treatments.
More than 550 laser industry professionals and students attended the Laser Institute of America's (LIA) 24th International Congress on Applications of Lasers & Electro-Optics (ICALEO) in Miami. The conference provided networking and educational opportunities, and covered hot topics within the laser industry. 800-345-2737