Twelve years ago Larada Sciences revolutionized the professional lice-treatment industry with its FDA-cleared AirAllé device, which uses heated air to kill head lice and 99.2 percent of nits (lice eggs). Since then, Lice Clinics of America franchisees have exclusively used the device to safely and successfully treat more than 825,000 lice infestations. Recently, a small number of competing lice businesses have attempted to capitalize on that success by treating children with air-generating devices that have not been reviewed or cleared by the FDA for use in lice treatments.
Some professional lice businesses are treating their clients using bonnet-style hair dryers usually found in salons. Others are using products meant for pets, such as pet-drying devices used in dog salons or animal warming devices used in veterinary clinics. And some are using a cold-air device meant for cooling the skin during tattoo laser removal. Although the treatment methods may differ, all of those lice businesses are claiming that the products they use kill lice.
Because the FDA classifies these types of lice-treatment products as medical devices, device manufacturers are supposed to submit safety and efficacy claims to the FDA prior to getting clearance to market or use their devices. Currently, the only product on the market that has been cleared by the FDA to use air in treating head lice is the AirAllé device.
“As a parent and a physician, I am concerned about families getting treated with unvalidated or re-purposed devices without the proper oversight,” says Dr. Krista Lauer, national medical director at Lice Clinics of America. “I would never use a medical device in my own practice if I knew it did not have FDA clearance for its intended use.”
Rainya Strack, a school nurse in St. Cloud, Minnesota, says she too is troubled by the proliferation of these devices that were not originally designed for treating lice. For many years she operated a lice clinic using the AirAllé device where she learned firsthand how important it is to provide families with not only safe, effective treatments, but also accurate information.
“Parents already freak out when their kids get lice, so I can only imagine how they would react if they knew the device used on their kid was intended for dogs or tattoo removal,” says Strack. “Parents deserve to know whether the treatments they are paying for have been approved by the FDA.”
The two devices she finds most troubling are the Lice-Tech device and the Zyma cold-air device. The Lice-Tech device is actually a Chinese product that blows warm air into an inflatable mattress for animals to lie on and stay warm during veterinary procedures. The device has been retrofitted with an applicator tip instead of the mattress at the end of its hose.
The Zyma device is actually a product called Cryo 6, which has been cleared by the FDA as a Class II medical device to “minimize pain and thermal injury during laser and dermatological treatments.”
Another heated-air product, FloSonix, blows air at a cooler temperature than has been found to significantly kill lice eggs. Because the manufacturer suggests having customers treat themselves with a topical lice-killing oil before and after a FloSonix treatment, and the FDA has not reviewed the manufacturer’s claims, it is unclear whether the device works.
Claire Roberts, CEO of Lice Clinics of America, said she wants parents to know they can trust getting treated at any one of their 150 U.S. clinics. “Our certified technicians will use an FDA-cleared medical device to get your children’s head lice eradicated safely in less than an hour, guaranteed. No pesticides, no gimmicks, no false advertising, no bait-and-switch. It is the same honest, safe and effective treatment we’ve been providing for the past 12 years. With over 20,000 5-star reviews, parents can rest assured they are in good hands at Lice Clinics of America,” said Roberts. About Lice Clinics of America Lice Clinics of America (www.liceclinicsofamerica.com) provides lice-treatment services through its network of franchised clinics. It has successfully treated more than 825,000 cases of head lice using its patented heated-air device, AirAllé. Lice Clinics of America and AirAllé (www.airalle.com) are brands owned by Larada Sciences, Inc., which is headquartered in Salt Lake City, Utah.