FDA variance for a laser light show.

Does anyone have any experience with obtaining an FDA variance from 21 CFR 1040.11(c) for a laser light show?

The show in question would use a small number of Class IIIb lasers (6 to 12 lasers), would be fully manually controlled, and would involve no crowd scanning or other bystander exposure (other than diffuse atmospheric scatter). The show would be intended for use at public musical events as an accent to the more typical colored stage lights. All beams would be directed well above the heads of any observers, and no person would be directly exposed to any beam at any time.

How difficult is it to obtain a variance for a system like this? What issues or problems did you encounter? Did your local health department have anything to say about your operating a laser show?

Any advice or perspective on this matter would be greatly appreciated.

Probably better to ask over at PL.

Getting a variance is rather difficult, if I recall correctly.

Trevor

In case the op doesn't now what Pl stands for it stands for Photon Lexicon, a laser website.

Here's the link to the variance you'll need to fill out.
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM080788.pdf