A Safety Alert for Users of Laser-Equipped Machinery
March 31, 2025Comments
The U.S. FDA retired its laser product standards, Laser Notice No. 50, on December 31, 2024, ushering in a new era of stricter regulations for the industry. On January 1, 2025, all manufacturers, sellers and buyers of laser-equipped machinery now must comply with updated guidelines under Laser Notice No. 56. These rules, which align with the latest International Electrotechnical Commission standards, place a heightened focus on global harmonization and safety. The shift marked a significant change in how laser products are evaluated, to help ensure consistency in their design and use globally.
Immediately after, in January 2025, the FDA posted a recall announcement issued by Chinese laser-cutting-machine manufacturer Bodor addressed to “all dealers and purchasers that the [P or C] series product(s) purchased from Bodor may require an update.” The recall encompassed safety concerns related to the protective housing of the machines, and the side-door safety interlocks. The FDA followed up in February by issuing an Import Alert citing “noncompliant submissions of electronic products to which is not affixed a certification in the form of a label or tag.”