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Warning Label Requirements for Multiple Wavelength and Dye Laser Products

This guidance provides clarification on the wording requirements for warning labels on dye lasers and other multiple wavelength laser products, specifically addressing the challenges in labeling devices that can emit multiple wavelengths of laser radiation.

  1. Review current warning labels on multiple wavelength laser products to ensure compliance with the guidance
  2. Update warning logotypes to include appropriate wavelength range information
  3. Ensure instruction manuals contain detailed information about wavelengths and maximum output
  4. Include clear references to pumping laser specifications where applicable
  5. Implement the approved warning label format using “visible and/or invisible radiation” terminology
  6. Ensure all required information about maximum output dependencies is clearly stated
  7. Maintain comprehensive documentation of warning label compliance

Key Considerations

Labelling

  • Warning labels must use “visible and/or invisible” to precede the word “radiation” when the laser can produce either or both types
  • For dye lasers, the warning logotype should include one of these statements:
    • “DYE LASER - VARIOUS ULTRAVIOLET, VISIBLE OR INFRARED WAVELENGTHS MAY BE EMITTED. CONSULT INSTRUCTION MANUAL.”
    • “DYE LASER - WAVELENGTHS EMITTED MAY RANGE FROM nm to nm. CONSULT INSTRUCTION MANUAL.”
  • Maximum output information should reference dependence on pumping laser
  • Additional note referring to operation/instruction manual is permitted
  • For maximum output level, include statement such as: “MAXIMUM OUTPUT DEPENDS ON DYE, MIRRORS AND PUMPING LASER - CONSULT INSTRUCTION MANUAL AND LABEL ON PUMPING LASER FOR MAXIMUM POWER.”

Safety

  • 21 CFR 1040.10(g): Performance Standards for Light-Emitting Products

Original guidance

  • Warning Label Requirements for Multiple Wavelength and Dye Laser Products
  • HTML / PDF
  • Issue date: 1977-03-02
  • Last changed date: 2020-03-16
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products, Radiological Health
  • ReguVirta summary file ID: 4f5edc67b43b38ca244680e0905a115a
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