U.S. FDA/CDRH Safety Standards and Registration (Notification) for Laser Products

In recent years, the planned abolition of FDA Laser Notice 50 has been announced in the United States, and in Europe, regulations such as EN 60825-1+A11 and EN 50689 have been issued, leading to significant changes in regulations regarding laser products. Do you have any concerns about compliance with safety standards for laser products being shipped to the U.S. or Europe in relation to these regulations and standards? To address such customer inquiries and concerns, we will hold a free individual consultation session regarding compliance with safety standards for laser products. Our experienced specialists from UL Solutions, which has a 130-year history and leads safety science through a global network, will carefully answer your questions and concerns. You can check the details of the technical consultation session by clicking the "Details & Application" button below.

Regarding "electric disinfectors" equipped with germicidal lamps, the interpretation of technical standards (Appendix Table 8) and the interpretation of the scope of electrical appliances under the Electrical Appliance and Material Safety Law have been revised (Revised and enforced: December 28, 2021). As a result of this revision, it has been clarified that "electric disinfectors" are subject to the regulations of the Electrical Appliance and Material Safety Law not only for those that emit germicidal light solely within the device but also for those that emit light outside the device. Businesses that manufacture or import relevant products need to confirm compliance with the technical standards. The revised interpretation of technical standards (Appendix Table 8) requires consideration of the photobiological safety of electric disinfectors. UL provides services to support the confirmation of compliance with technical standards based on these interpretations. For more details, please check the "Related Links" below.

In recent years, products using lasers and LEDs have been on the rise. Various products such as laser projectors, laser lighting, LiDAR/Time-of-Flight (TOF) sensors, head-up displays (HUD), 3D printers, and UV-C related products for Covid-19 measures have been adopted, and we have received many inquiries from our customers regarding evaluations. UL is pleased to announce that we will hold an online technical consultation session regarding compliance with light radiation safety standards for laser and LED-equipped products in response to customer requests. Experienced evaluation engineers from UL, a globally recognized third-party safety science organization, will be available to answer inquiries and questions from manufacturers developing related products. Typically, technical consultations are charged, but during this campaign period, they will be available for free, so we encourage you to take advantage of this opportunity. For examples of consultations and details about the free technical consultation session, please check the "Details & Application" link below.