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Laser Light Shows and Demonstration Laser Products: Performance Standards and Manufacturer Requirements

This guidance clarifies the applicability of the Laser Product Performance Standard to laser light shows used in music, entertainment, and advertising industries. It defines who is considered a manufacturer and outlines compliance requirements for demonstration laser products.

  1. Determine if your laser light show activities classify you as a “manufacturer”
  2. Verify the manufacturing date of your laser products to determine applicability of standards
  3. Ensure compliance with Class I or Class II laser product requirements
  4. Apply for variance if unable to comply with standard requirements
  5. Implement adequate safety controls for both stationary and mobile light shows
  6. Maintain certification documentation for products manufactured after August 2, 1976
  7. Monitor for any updates to 21 CFR 1040.11(c) regarding demonstration laser products
  8. Establish a process for recertification when modifications are made to existing systems

Key Considerations

Safety

  • Demonstration laser products must comply with Class I or Class II laser product requirements
  • Must not exceed accessible emission limits of Class I or Class II
  • Adequate controls required for both stationary and mobile light shows
  • Variance required if product cannot comply with 21 CFR 1040.10 or 1040.11

Other considerations

  • 21 CFR 1040.10: Performance Standards for Light-Emitting Products
  • 21 CFR 1040.11: Specific Purpose Laser Products
  • 21 CFR 1010.4: Variances

Original guidance

  • Laser Light Shows and Demonstration Laser Products: Performance Standards and Manufacturer Requirements
  • HTML / PDF
  • Issue date: 1977-11-23
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products
  • ReguVirta summary file ID: ba4da514dd69b59d00496d6375bd6fcc
This post is licensed under CC BY 4.0 by the author.