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This document is an application submitted to the FDA for approval to operate a laser light show that does not comply with specific regulations under 21 CFR 1040.11(c). It details the applicant's information,

How to fill out application for a variance

How to fill out APPLICATION FOR A VARIANCE FROM 21 CFR 1040.11(c) FOR A LASER LIGHT SHOW, DISPLAY OR DEVICE

1. Gather necessary information about the laser light show, display, or device you plan to implement.
2. Review the requirements outlined in 21 CFR 1040.11(c) to understand what variances may be needed.
3. Complete the application form, ensuring all sections are filled out accurately.
4. Include detailed descriptions of the laser system's specifications, including the type, power output, and safety measures.
5. Provide information about the event or purpose of the laser display, including location and audience size.
6. Document any safety measures or precautions you will implement to protect the public and environment.
7. Attach any supporting documents, such as engineering studies, safety analyses, or previous variance approvals.
8. Review the application for completeness and accuracy, making any necessary revisions.
9. Submit the application to the appropriate authority, adhering to any specific submission guidelines or deadlines.

Who needs APPLICATION FOR A VARIANCE FROM 21 CFR 1040.11(c) FOR A LASER LIGHT SHOW, DISPLAY OR DEVICE?

1. Event organizers planning a laser light show or display.
2. Businesses seeking to use lasers for promotional purposes.
3. Artists or performers incorporating laser displays into their acts.
4. Facilities that intend to host laser exhibitions or entertainment events.
5. Any entity that requires compliance with safety regulations for laser usage.

People Also Ask about

Do lasers need to be FDA approved?

The FDA regulates both medical and non-medical lasers. The FDA may inspect manufacturers of laser products and require the recall of products that don't comply with federal standards or that have radiation safety defects.

Do you have to register a laser?

A separate registration is required for each location of intended use. Out-of-state lasers brought into the state for temporary use require notification to the State Bureau of Radiation. The Laser Safety Officer must establish and supervise a program of laser radiation safety for compliance with all applicable rules.

Are class 5 lasers illegal?

Under federal law, it is perfectly legal to sell any laser above 5 mW as long as the laser complies with FDA/CDRH laser product requirements for labels, safety features, quality control, etc. AND as long as the laser is not promoted as a “laser pointer” or for pointing purposes.

How long does it take to get laser variance?

The variance process depends on the the U.S. government's FDA, so most variance approvals take approximately 6-8 weeks. For comparison, attempting to acquire an FDA laser variance independently can take up to two years.

For pdfFiller’s FAQs

What is APPLICATION FOR A VARIANCE FROM 21 CFR 1040.11(c) FOR A LASER LIGHT SHOW, DISPLAY OR DEVICE?

It is a formal request submitted to the FDA to seek exemption from certain regulatory requirements outlined in 21 CFR 1040.11(c) related to laser light shows, displays, or devices, typically due to unique circumstances or for the purposes of artistic expression.

Who is required to file APPLICATION FOR A VARIANCE FROM 21 CFR 1040.11(c) FOR A LASER LIGHT SHOW, DISPLAY OR DEVICE?

Individuals or organizations planning to conduct a laser light show or use laser devices that do not comply with the standard safety regulations set forth in 21 CFR 1040.11(c) are required to file this application.

How to fill out APPLICATION FOR A VARIANCE FROM 21 CFR 1040.11(c) FOR A LASER LIGHT SHOW, DISPLAY OR DEVICE?

The application form typically requires applicants to provide detailed information about the laser show or device, including technical specifications, safety measures, and any mitigating factors that justify the request for a variance. Applicants may need to include diagrams, risk assessments, and proposed safety protocols.

What is the purpose of APPLICATION FOR A VARIANCE FROM 21 CFR 1040.11(c) FOR A LASER LIGHT SHOW, DISPLAY OR DEVICE?

The purpose is to allow for innovative or artistic uses of laser technology while ensuring that public safety is maintained, by allowing for exceptions to the standard regulations where appropriate and justified.

What information must be reported on APPLICATION FOR A VARIANCE FROM 21 CFR 1040.11(c) FOR A LASER LIGHT SHOW, DISPLAY OR DEVICE?

Applicants must report details such as the type and purpose of the laser device, the locations and durations of the shows, safety measures implemented, any anticipated risks, and how those risks will be mitigated. Additionally, previous experience with similar displays may be requested.