April 2008 Issues

FDA Advisory Committee Reaffirms Lasik Safety but Recommends Clearer Labeling -- Quick Pulse

Summary: An estimated 6 million Americans have had LASIK (laser-assisted in situ keratomileusis) eye surgery to reduce their dependency on eyeglasses or contact lenses. The FDA’s Ophthalmic Devices Advisory Committee in the Center for Devices and Radiological Health (CDRH) met to discuss whether there is enough information about potential problems with LASIK and with phakic intraocular lenses (IOLs) in patient labeling and on the FDA’s website and whether that information should be modified. The FDA does not regulate LASIK; it only regulates the equipment used in the procedure.

2008 Annual American Society For Laser Medicine And Surgery (ASLMS)

Summary: Fractional CO2 and non-invasive procedures received the most attention at ASLMS, both in terms of buzz and in the number of new products. ♦ The laser market is very competitive, but laser prices are holding relatively steady, with mostly normal discounting. ♦ The U.S. economic downturn did not appear to be discouraging doctors attending ASLMS from cutting back drastically on laser or cosmetic device purchases, but doctors also didn’t have long shopping lists this year. Industry officials offered a mixed sales outlook. ♦ Doctors expressed interest in a wide variety of products, including fractional lasers, new handpieces for existing devices, hair removal, skin tightening, fat removal, and semi-ablative fractional lasers. ♦ Lumenis, Reliant, and Cynosure appeared to be the leaders, but Candela, Cutera, and Alma Lasers are not far behind. Thermage and Palomar generated little excitement.