Form Approved: OMB No. 09100025 Expiration Date: August 31, 2023FORM FDA 3640 (2/21) Reporting Guide for Laser Light Shows and DisplaysPublic reporting burden for this collection of information is.
Open form follow the instructions
Easily sign the form with your finger
Send filled & signed form or save
How to fill out the HHS FDA 3640 online
The HHS FDA 3640 form is essential for reporting laser light shows and displays that utilize Class IIIb or Class IV lasers. This guide provides clear, step-by-step instructions to help users navigate the process of completing this form online.
Follow the steps to effectively fill out the HHS FDA 3640 form.
- Click the 'Get Form' button to access the HHS FDA 3640 online form and open it in your editor.
- Begin with Part 1: Identification of Manufacturer. Enter the name, address, and contact information of the manufacturer of the laser light show. Ensure that the responsible person's details are included and certify the accuracy of the provided information.
- Move to Part 2: Identification of Report. Indicate if the submission is a new report or a supplemental report by checking the corresponding box. Provide the date of the report and, if applicable, the CDRH accession number of the report it supplements.
- In Part 3, provide the name(s) of the light show or display. Make sure this aligns with the schedule outlined in Part 7.
- Proceed to Part 4: Variance. Attach a copy of either your variance application or the approval letter, checking the box to confirm attachment.
- In Part 5: Projection Equipment, list each projector used in the show, including the manufacturer, model number, and any CDRH variance number.
- For Part 6: Show Venue, select the appropriate venue type from the options provided, detailing if it's a fixed location or various tour locations.
- In Part 7, detail the specific locations, dates, and times of the shows. This information must be accurate and comprehensive.
- For Part 8: Light Show Effects Produced, check all applicable types of laser effects that will be used during the show.
- Create diagrams and drawings of the show venue in Part 9. Include both plan and elevation views, detailing all laser and audience locations.
- In Part 10: Laser Radiation Levels, describe the methodology for determining the radiation levels indicated in the previous diagrams.
- Complete Part 11 regarding Scanning Safeguards, addressing whether audience scanning will occur and describe safeguards in place.
- In Part 12: Operator Controls, confirm that an operator is designated to control the show continuously, detailing their responsibilities.
- Part 13 addresses Projection Equipment Controls, confirming the presence and accessibility of controls to immediately terminate laser radiation.
- Attach detailed written test procedures in Part 14 and confirm the availability of records for quality assurance purposes.
- Finally, in Part 15: Notification Procedures, outline the methods for notifying relevant authorities and include any associated documentation.
- Once all information is completed and verified, save changes to the form, then download, print, or share the completed form as needed.
Complete your laser light show report and ensure compliance by filling out the HHS FDA 3640 form online today.
Experience a faster way to fill out and sign forms on the web. Access the most extensive library of templates available.
Related content
Get answers to your most pressing questions about US Legal Forms API.
How does a laser light show work?
7:06 9:30 How Things Work: Laser Light Shows - YouTube YouTube Start of suggested clip End of suggested clip You can also write letters. Remember the laser is always on. And it's scanning and these mirrors areMoreYou can also write letters. Remember the laser is always on. And it's scanning and these mirrors are moving very very fast to direct the beam where you want it to go.
What is the FDA variance for lasers?
Under condition 13(a) of the variance application, beams must be kept at least 2.5 meters laterally and 3.0 meters vertically from audience access. This means laser beams should be kept approximately 10 feet above any surface upon which someone can stand, and approximately 8 feet in lateral separation.
What are the 3 types of lasers?
Types of Lasers Gas. Liquid. Semiconductor. Solid-State. Fiber.
Which laser is used in laser projector?
He-Ne laser had been used in early days and later multi-colored mixed gas laser is used for high end laser projector.
Why does the FDA regulate lasers?
But the agency is concerned about the misuse of these potentially dangerous devices and their increased availability for purchase on the Internet. Laser pointers are misused when they are directed at people or treated as toys.
Are laser light shows safe?
For shows where the laser beam could fall on the crowd, the power of the laser is kept below levels know to be hazardous. Risks from improperly handled lasers include: Eye injury. Skin burns.
Which laser is used in laser light show?
DPSS lasers used a very high powered infrared light source, which was then focused onto a specific crystal (Nd:Yag) to create various lasers wavelengths (colors). Most recently, diode laser technology has become the standard for laser show laser modules.
How are laser light shows made?
To produce pictures on a screen or wall during a laser show, two galvanometers—dubbed “galvos” in the indus- try—use electrical signals to make small mirrors vibrate over a two-dimensional plane. The moving mirrors reflect the beam path fast enough to trace a shape on a target wall or screen.
Use professional pre-built templates to fill in and sign documents online faster. Get access to thousands of forms.
If you believe that this page should be taken down, please follow our DMCA take down process here.