This Variance request is for UNO LASER fixtures Only.
The variance application process with electronic signature should only take a few minutes.
What is a Laser Variance?
A "Laser Manufacturer Variance" is a special "permit" issued and regulated by the FDA (Food and Drug Administration) and the CDRH (Center for Devices and Radiological Health) which allows a product manufacturer to make and publicly distribute laser light devices in the United States. This is used to regulate and control the amount of Radialogical Exposure the general public may incur while these devices are operating in any designated venue according to the FDA guidelines for Manufacturers and distributors detailed in the FDA's Laser Notice 51.
After you complete UNO LASER e-signature Variance Application process you may download a copy of your application on the final screen. A copy of this application will be sent to the FDA by mail.
Expect to receive between two and four letters from the FDA/CDRH. The first letter or two will be an acknowledgement that your documents have been received. This letter should arrive in 2-3 weeks. The final letter(s) will be your formal approval and will follow the acknowledgement by 3-6 weeks.
Your variance will cover FDA/CDRH certified and compliant Class 3B & 4 UNO Laser Fixture products only.