What is an FDA variance?
There are several laws and requirements which govern use of high powered lasers such as X-laser systems. These laws restrict the use of such laser systems in much the same way as laws which govern the driving of a car. A variance is essentially a federal license to operate high power laser systems and you are required to have one just as you are required to have a driver's license before driving a car. However, despite the many misconceptions about variances, they are easy to get and have little or no cost associated with obtaining them.
The point of a variance is to make sure that you, as the user of a laser product, are well versed in basic laser safety and that you are committed to using laser products safely. You wouldn't want to be on the road with someone who never learned how to drive nor would you want to be in a club with a high power laser operated by someone who does not know how to use it. Information on obtaining a variance is included in this site for your convenience and a variance application is included with every X-Laser product.
Do I need a variance?
Getting a variance is a great idea if you are using ANY type of laser systems. It is fast, convenient, and very inexpensive or even free. You are required to have a variance if you want to use any laser more powerful than 4.95mW. (See more information about power levels in the Laser Power FAQ) Getting a variance will keep you legal, VASTLY expand the types of laser shows you can perform, and help to protect you in that worst-case-scenario if audience member suffers an injury (real or imagined) from your show.
I have heard that getting variances are really hard and time consuming. Is that true?
It sure can be but not with a pre-made X-Laser EZ variance kit! A variance application has two main parts: the application itself and the show report. The application can be filled out in less than 10 minutes with information supplied from the manufacturer of your laser. The show report section includes a lot of questions and a couple of basic diagrams. However, a professionally completed variance application is included with every X-Laser unit and can also be provided by your dealer.
How long does approval take?
That depends on a branch of the FDA known as the CDRH. Generally you get a letter from the CDRH acknowledging your submission within a couple of weeks and the formal variance approval follows sometime thereafter. Current estimates from the CDRH are about two weeks for approval but that time frame is dependant on their work load.
Are there any other requirements which need to be met?
Laws vary by state and we strongly suggest looking up the laws of your jurisdiction. Other than a few states having additional requirements, a daily safety checklist is required for each day you use your laser system in a performance. An example of this checklist is included with your laser unit for your convenience. Secondly, warning signs need to be posted at any venue in which a high power laser is being used and finally, you will need to provide certain agencies at least 24 hours notice that you will be conducting a high power laser light show. This is very quick and easy to do either by e-mail, fax, or postal mail and again, a sample form has been included for you on your product CD.
Is it worth getting a variance?
Absolutely. Both to reduce your liability and to stay in compliance with the law, we cannot recommend it strongly enough. And really, what do you have to lose? Five minutes to sign (and/or mail) the completed forms is well worth the impact you can make on your customers and guests with high power laser light shows.
Can any high power laser be used under a variance?
No. Lasers used under a variance MUST be certified by the FDA. That is something that the manufacturer takes care of for you and FDA certified lasers are critical to putting on good shows, safely. Lots of cheap un-certified lasers are available on the internet and the vast majority of them lack even the most basic safety features to protect you, your staff, and everyone else from serious radiation injuries and blindness. With a certified laser you know what you are getting and you know that your show won't get shut down for using illegal, dangerous products. Fines for using un-certified lasers, even unknowingly, stand at approximately $300,000.00 per performance. No kidding.
ALL X-Laser Performance Laser Systems are FDA certified, compliant, and included detailed safety instructions for your peace of mind.
Is the variance application included with my X-Laser guaranteed to be approved?
The FDA reserves the right to approve or disapprove any submission and that part we have no control over. However, your variance application will have been prepared by an expert laser consultant and is indeed very similar to the forms that we used ourselves when we had to apply for our own variances. So it is very unlikely that it would not be easily approved but, if for whatever reason there are any difficulties, please let us know and we will make any required changes for you.
