Are LEDs or IPLs subject to the laser regulations and reporting?
21 CFR 1040.10(b)(19) Laser means any device that can be made to produce or amplify electromagnetic radiation at wavelengths greater than 250 nm but less than or equal to 13,000 nm or, after August 20, 1986, at wavelengths equal to or greater than 180 nm but less than or equal to 1.0*106nm primarily by the process of controlled stimulated emission. Since they do not meet the definition of a laser as the source of the light (and assuming the products do not otherwise incorporate a laser), they are not subject to the laser standard. There is no existing FDA performance standard for Light emitting diodes or Intense Pulsed Light products. They are not subject to Product or Annual reports under 21 CFR 1002. However, as they are radiation-emitting products, the manufacturers of these products would still be subject to the general requirements in Title 21 CFR 1000 through 1005, specifically, accidental radiation occurrence notifications and notifications of defect, 21 CFR 1003 & 1004.
