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).
What You Need to Know? 👇
What defines a laser product under FDA regulations?
A laser product must generate or amplify electromagnetic radiation through stimulated emission. Simply providing energy to excite laser media doesn’t qualify a device as a laser product under 21 CFR 1040.10(b)(17).
Are electron beam accelerators considered laser products by the FDA?
No, electron beam accelerators that only provide excitation energy for laser media are not classified as laser products, even if marketed for laser applications, according to FDA advisory opinions.
Do energy sources for lasers require separate FDA compliance?
Energy sources like electron beam accelerators that don’t directly produce laser radiation are not subject to laser product regulations (21 CFR 1040.10 and 1040.11) as separate entities.
Can advertising affect FDA device classification for laser products?
Marketing a device for laser applications doesn’t automatically change its regulatory classification. The device’s actual function and design determine whether it meets laser product criteria under FDA regulations.
What’s the difference between laser products and laser energy sources?
Laser products generate or amplify coherent light through stimulated emission. Laser energy sources only provide power or excitation energy to enable laser operation but don’t produce laser radiation themselves.
When was FDA’s position on laser energy sources established?
The FDA clarified its position on laser energy sources not being classified as laser products in November 1975 through Policy Statement #2, providing regulatory clarity for manufacturers.
What You Need to Do 👇
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