Palomar Delays Launch of Home-Use Hair Removal Device
Palomar Medical Technologies of Burlington, Mass., said it has extended the launch date of a home-use, light-based hair removal device it is developing with Gillette until Feb. 29 at the latest. In the meantime, the companies said they will renogiate their development agreement. The device would be the first light-based hair removal product to receive 510(k) over-the-counter clearance from the FDA. OTC clearance allows it to be marketed and sold directly to consumers without a prescription. Gillette and Palomar have conducted more than 11 clinical studies on more than 600 subjects which the companies said demonstrate the device delivers "comfortable, effective, skin-safe hair removal." Palomar CEO Joseph P. Caruso said, "Together with Gillette we have developed game-changing technology with the potential for a tremendous impact on women's everyday lives. We are looking forward to advancing this technology into the consumer market with a strategy designed to increase consumer awareness." In 1997, Palomar introduced the first high-powered laser hair removal system for professional use. The company is also working with Johnson & Johnson on home-use, light- based devices designed for skin care, including cellulite, aging skin and acne treatments.