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Use of Visible Laser Beam as Emission Indicator for Class II and Class IIIa Laser Products

This guidance addresses the use of emitted laser beam as an emission indicator for Class II and Class IIIa laser products, specifically focusing on visible laser radiation. It aims to align CDRH standards with international standards (IEC and ANSI) regarding emission indicators requirements.

  1. Review current emission indicator designs for Class II and Class IIIa laser products
  2. Consider using the emitted laser beam itself as the emission indicator for visible laser radiation
  3. Document the rationale for using the laser beam as the emission indicator in technical documentation
  4. Monitor for future amendments to the standard regarding beam attenuators and emission indicators
  5. Ensure compliance with other applicable requirements of 21 CFR 1040.10 not affected by this notice
  6. Consider alignment with international standards (IEC and ANSI) for emission indicator requirements

Key Considerations

Human Factors

  • The emitted beam must be observable by the operator for certain types of visible laser products to perform their intended functions (leveling, pointing, or aiming)
  • It is considered unlikely that laser safety eyewear would be used with Class II or Class IIIa laser products

Safety

  • The emitted laser beam itself can serve as the indication of emission of visible laser radiation
  • Previous requirement (21 CFR 1040.10(f)(5)(i)) for Class II and Class IIIa laser systems to incorporate a visible or audible emission indicator is no longer enforced

Other considerations

  • IEC 825-1:1994: Safety of laser products
  • ANSI Z136.1:1993: Safe Use of Lasers

Original guidance

  • Use of Visible Laser Beam as Emission Indicator for Class II and Class IIIa Laser Products
  • HTML / PDF
  • Issue date: 1996-09-05
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products
  • ReguVirta summary file ID: dd4d5ee7c2e46c1773f47b6aa9ff336c
This post is licensed under CC BY 4.0 by the author.