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Classification of Electron Beam Accelerators Used as Laser Energy Sources

This guidance clarifies whether an electron beam accelerator that can provide excitation energy for laser media should be classified as a laser product under 21 CFR 1040.10(b)(17).

  1. Classify electron beam accelerators based on their primary function rather than potential secondary applications
  2. Do not apply laser product regulations to electron beam accelerators solely because they can be used as laser energy sources
  3. Ensure marketing materials clearly distinguish between the device’s primary function and potential applications
  4. Document the regulatory classification rationale based on the device’s primary intended use
  5. Maintain compliance with applicable electron beam accelerator regulations rather than laser product standards

Key Considerations

Safety

  • An electron beam accelerator that can be used as a laser energy source is not automatically classified as a laser product
  • The potential use of the accelerator for laser applications does not make it subject to laser product regulations

Other considerations

  • 21 CFR 1040.10: Performance Standards for Light-Emitting Products
  • 21 CFR 1040.11: Specific Purpose Laser Products

Original guidance

  • Classification of Electron Beam Accelerators Used as Laser Energy Sources
  • HTML / PDF
  • Issue date: 1975-11-21
  • Last changed date: 2020-03-16
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products
  • ReguVirta summary file ID: 3b70b5be46bd064e4f847455b828d63f
This post is licensed under CC BY 4.0 by the author.