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.
Recommended Actions
- Determine if your laser light show activities classify you as a “manufacturer”
- Verify the manufacturing date of your laser products to determine applicability of standards
- Ensure compliance with Class I or Class II laser product requirements
- Apply for variance if unable to comply with standard requirements
- Implement adequate safety controls for both stationary and mobile light shows
- Maintain certification documentation for products manufactured after August 2, 1976
- Monitor for any updates to 21 CFR 1040.11(c) regarding demonstration laser products
- 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
- Any person commercially selling services as a manufacturer or assembler of light shows is considered a “manufacturer”
- Assembly of a laser light show using previously manufactured laser creates a “new” product
- Products manufactured after August 2, 1976, are subject to certification and recertification if “remanufactured”
- Products manufactured before August 2, 1976, but “remanufactured” after this date are subject to the standard
- Products manufactured and “remanufactured” before August 2, 1976, are not subject to the standard
Relevant Guidances
- Laser Products - Performance Standards and Safety Requirements
- 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
- Alternative Warning Statements for Laser Product User Information
- Beam Attenuator and Emission Indicator Requirements for Class II and IIIa Visible Laser Systems
- Laser Light Shows and Displays: Requirements for Aircraft Safety and Visual Control
- Use of Visible Laser Beam as Emission Indicator for Class II and Class IIIa Laser Products
- Alternative Identification Labeling Requirements for Class I Laser Products Integrated into Other Products
- Significant Risk Determination for Investigational Medical Laser Devices
- Classification of Electron Beam Accelerators Used as Laser Energy Sources
- In-House Manufactured Laser Products: Applicability of Federal Performance Standards
- Safety Requirements for Medical Laser Delivery Systems and Interlock Mechanisms
- Remote Interlock Connector Requirements for Laser Products
- User Instructions for Medical Laser Products: Safety Information and Radiation Hazard Protection Requirements
- Reproduction of Hazard Warning Labels in User Instructions for Laser Products with Cosmetic Enclosures
- Warning Label Requirements for Multiple Wavelength and Dye Laser Products
Related references and norms
- 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
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