Laser Light Show Variance Renewal and Amendment Procedures
This guidance outlines procedures for renewal and amendment of laser light show variances, specifically for Class IIIb or IV laser shows that exceed Class IIIa demonstration laser product limits. It aims to streamline the variance renewal process while maintaining public safety standards.
Recommended Actions
- Review current variance status and ensure it meets the criteria for automatic renewal
- Implement system for timely submission of annual reports by September 1st
- Maintain comprehensive documentation of all laser projectors used in shows
- Create and maintain records of setup, alignment, and testing procedures
- Establish process for tracking and reporting any radiation-related incidents
- Keep copies of Laser Notice 55, variance amendment notice, annual reports, and CDRH acknowledgments with show records
- Implement system to track and verify compliance with all variance conditions
- Create procedure for identifying and reporting any product defects or compliance issues
Key Considerations
Safety
- Annual reports must be submitted by September 1st, covering the previous 12-month period
- Setup, alignment, and testing procedures records must be maintained
- Accidental radiation occurrences must be reported
- Normal clearance distances must be maintained
- Only visible wavelength range (400-700 nm) emissions are permitted under this guidance
Other considerations
- Manufacturers must maintain product reports for new shows and projectors
- Supplemental reports required for changes affecting radiation emission
- Records retention requirements per 21 CFR 1002.30(a) and 1002.31
- Notification of defects or compliance failures required
- Manufacturers must repurchase, repair, or replace non-compliant products
- Variances can be withdrawn if public health or safety is at risk
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
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
- 21 CFR 1002: Records and Reports
Original guidance
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