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).
Recommended Actions
- Classify electron beam accelerators based on their primary function rather than potential secondary applications
- Do not apply laser product regulations to electron beam accelerators solely because they can be used as laser energy sources
- Ensure marketing materials clearly distinguish between the device’s primary function and potential applications
- Document the regulatory classification rationale based on the device’s primary intended use
- 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
- Advertising the accelerator for potential use in laser systems does not classify the device as a laser product
- The device’s primary function as an electron beam accelerator takes precedence over its potential secondary use in laser applications
Relevant Guidances
- Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 Standards
- Laser Illuminated Projectors (LIPs) - Classification, Safety Requirements and Labeling
- Laser Products - Performance Standards and Safety Requirements
Related references and norms
- 21 CFR 1040.10: Performance Standards for Light-Emitting Products
- 21 CFR 1040.11: Specific Purpose Laser Products
Original guidance
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