FDA still busy approving MD hair removal lasers
In December 1999, the Iridex Corporation issued a press release from Company offices in Mountain View, California, announcing that it had received clearance from the U.S. Food & Drug Administration for its Iriderm Apex 800 diode laser system for hair removal. The Company claims its device is the first fiber-optically delivered, high-powered, diode laser system to be cleared for this purpose.
The first device to employ fiber optics to deliver laser energy to the base of hair follicles was developed at Michigan’s Wayne State University in the early 1990s by a research team headed by Dr. Ken Hashimoto. Paradigm Lasers Inc., of Rochester, N.Y. financed the development of Dr. Hashimoto’s probe-type laser epilator and introduced a prototype to electrologists at the joint 1995 convention of the American Electrology Association and International Guild of Professional Electrologists, in Reno, Nevada. Though the device offered a source of energy that could effectively destroy the hair papilla, Dr. Hashimoto admitted that there was a problem in delivering laser light through (optimum-size) optic fibers that might often be too big for insertion into small follicles. The epilator was expected to be expensive to use, electrologists were not very impressed, and the laser company apparently dropped the idea.
The makers of the new Iriderm Apex 800 diode laser system are not to be deterred. They say their device will “offer dermatologists, plastic surgeons and cosmetic surgeons a reliable and affordable laser system to expand their practice as well as provide patients with a fast and technologically advanced treatment for hair removal.
Mr. Bradley J. Renton, vice-president of Aesthetics for Iridex Corporation, says “Patient demand for laser hair removal is strong. We believe faster, effective treatments allowed by the Iriderm will expand the market by enabling more competitive patient fees. The Apex 800 combines the benefits of reliable semiconductor laser technology with speed, clinical efficacy and ergonomic delivery. These features differentiate the Apex 800 and make it a formidable competitor in the rapidly growing, $200 million per year hair removal laser market.”
Christopher Nanni, MD, clinical Instructor of Dermatology at New York University School of Medicine and in private practice in New York City said, “hair removal continues to be one of the most frequently requested laser procedures from patients in my practice. Physicians have been waiting for a hair removal laser that is fast and has low cost of ownership, while maintaining clinical efficacy and reliability. The Apex 800 exactly satisfies these needs.”
home
subscribe
advertise
about us
