By John O’Hagan
Laser technology and applications sometimes march ahead of laser safety standards. Lasers have been used in the aesthetic industry for many years. The availability of low-cost 808 nm laser diodes has triggered a whole industry of home-use devices for various treatments, such as hair removal (or more correctly hair “management”) and skin rejuvenation. The lasers used are typically Class 3B, but the device is intended to be used in contact with the skin, or at least in very close proximity.
The accessible emission limits (AELs) for the laser classes are intended for eye and skin exposure. However, a number of the manufacturers of the home-use devices have interpreted the AELs as only applying to the eye. Therefore, there are several devices on the market that are considered (incorrectly) to be Class 1. [click to continue…]
By Daniel X. Hammer, William Calhoun, Do-Hyun Kim, Robert James, Ilko K. Ilev and Victor Krauthamer
The Food and Drug Administration’s Center for Devices and Radiological Health (FDA/CDRH) regulates medical devices and radiological products in the US. We approve new devices that are deemed to be safe and effective and clear for sale devices which are substantially equivalent to older products. A large and growing number of medical devices include lasers and coherent optical sources that require special consideration in the approval process. Moreover, newly available sources and applications have characteristics that make determination of safety difficult. The Office of Science and Engineering Laboratories (OSEL) is the research arm of CDRH, providing basic and applied scientific expertise and consultative technical review to the FDA. OSEL has expertise in biology, physics, solid and fluid mechanics, chemistry and material science, imaging and applied mathematics, and electrical and software engineering. The Division of Physics (DP) has several active research programs that relate to device laser safety. This article summarizes a few of those projects. [click to continue…]