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Fraxel re:store Dual, a non-invasive laser resurfacing treatment, has been granted clearance by the FDA for the treatment of actinic keratosis (AK), also known as sun or precancerous spots.

The FDA clearance was given partly because of data from a six-month study of 21 patients with AK, each of whom underwent a series of two to four laser treatments, spaced two to four weeks apart. Results showed that the treatment yielded a mean 83.5 percent decrease in age spot lesions on the face and other areas of the body, including the arms, hands and chest. Improvements in skin texture and pigmentation were also reported.

“In our study, we found the Fraxel re:store Dual to be the most effective treatment of multiple facial AKs, as it is safe and requires minimal downtime while simultaneously improving other signs of photodamage,” said Dr. Roy G. Geronemus, director of the Laser and Skin Surgery Center of New York, in a news release. “While the 83.5 percent removal rate was comparable to other topical therapies and AK treatment options, Fraxel was overwhelmingly well-tolerated by all the patients and offers the added benefit of improving a patients’ overall skin quality, color and texture.”

Fraxel re:store Dual has a 1927 nm wavelength in addition to a 1550-nm deep-penetrating Erbium fiber laser. The 1927 nm wavelength is optimized for treatment of pigmentation and other superficial skin conditions, such as AK.

The FDA has also cleared Fraxel re:store for:

• Skin resurfacing
• Eye wrinkles
• Acne scars
• Surgical scars
• Skin discoloration and pigmented lesions, such as age spots and sun spots

Patients frequently travel to Dr. Stacy Cosmetic  in Bellevue, Washington, from across Washington, Alaska, Idaho and Oregon for Fraxel re:pair laser resurfacing treatment. Fraxel re:pair treatment has FDA clearances for wrinkles, irregular texture, sun and age spots and sun-induced redness.

SmartLipo is a type of liposuction that uses a laser to assist in the removal of unwanted body fat. This laser-assisted liposuction device removes fat and reshapes areas of the body with precision and less downtime than traditional surgical liposuction. 

With SmartLipo, the laser targets fat cells and dissolves the cells on contact; a gentle suction then removes the dissolved fat. It can be used on many areas of the body, including the abdomen, back, thighs, hips, knees, arms, neck, and chin. 

Skin tightening is another benefit that has been attributed to laser liposuction; fat removal alone can’t correct poor skin elasticity in older patients. But while makers of laser liposuction platforms have claimed that their systems can produce noticeable skin tightening after liposuction, most of the time they don’t cite clinical evidence to back up their claims. 

New Jersey plastic surgeon Dr. Barry DiBernardo recently published a study that evaluates the skin tightening effects of laser liposuction, comparing SmartLipo to traditional liposuction. He enrolled ten subjects who had both unwanted abdominal fat and a mild to moderate degree of loose skin. Each subject underwent liposuction or laser-assisted liposuction on a randomly selected side of the body. 

Patients were evaluated one month and three months post-operatively, and a noticeable difference was documented in skin shrinkage and tightening. “The mean skin shrinkage ratios were significantly higher on the laser-treated side than on the suction side,” Dr. DiBernardo said.

Dr. Stacy is nationally known for her ability to achieve results with SmartLipo, and patients often travel to her Bellevue, Washington practice from Alaska, Oregon, Idaho, and from across Washington for their treatment. View SmartLipo before and after photos of Dr. Stacy’s patients to see the results.

Allergan, the maker of Botox, has agreed to pay $600 million in fines for marketing their product for uses for which it hasn’t been FDA approved.

Documents released by the Justice Department outlined claims that Allergan had built Botox sales by promoting it for unapproved treatments to relieve conditions like migraines, muscle spasticity and cerebral palsy in children, according to the New York Times. Doctors are allowed to prescribe drugs in off-label ways that they deem medically appropriate, but it’s illegal for a drug maker to promote these off-label uses.

Allergan has denied the criminal and civil accusations, except for the one misbranding charge, said Caroline Van Hove, an Allergan spokeswoman.

While Botox is best known as a wrinkle fighter, it has been approved to treat a range of  muscle and gland disorders, including uncontrolled blinking and excessive underarm sweating, and its uses continue to grow.  The New York Times reports, ”This year, the agency again expanded the use of Botox, permitting injections for increased muscle stiffness in the elbows and hands, and it is now considering whether to approve Botox as a preventive treatment for severe migraines.” Allergan is also studying Botox as a treatment for overactive bladders, in addition to owning patents on several other potential treatments.

In an e-mail to a reporter,  Ms. Van Hove wrote, “I want to be clear that Allergan is not charged with misleading doctors or causing any patient harm, and we adamantly deny any implication that this occurred.”

She also stressed that Allergan has spent hundreds of millions of dollars in research and development of new uses for Botox. The drug is approved in 81 countries to treat 21 different conditions, she added.