CDRH laser device requirements can be found in CFR 21, Section I, subchapter J, parts 1002 to 1040. Laser products are classified into categories depending on the level of hazard they present. This hazard level is in turn based mainly on laser power output. Displaying title 21, up to date as of 5/07/2026. Choosing an item from citations and headings will bring you directly to the content. (C028) This equipment contains Class 1 laser products, and complies with FDA radiation Performance Standards, 21 CFR Subchapter J and the international laser safety standard IEC 825-2. Data processing. For purposes of the FDA's electronic product radiation control program, the terms "electronic product" and "electronic product radiation" are defined at 21 CFR 1000. See more Examples of Radiation-Emitting Electronic Products on our website. Other agencies such as the Federal Aviation Administration (FAA) and the Occupational Health. HHS is committed to making its websites and documents accessible to the widest possible audience, including individuals with disabilities.
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