Variance clarification

[MLS]

I have a question that I am sure most of you know that I cannot seem to find the answer to.

Scenario-

If I were to buy a diode/driver combo, say CNI, or something similar over 5mW and was just using this beam with no scanners/internal mirrors/galvos across a venue would this be approved? Basically projecting a solid beam at min. 3meters distance from human interaction. Obviously you have to be connected to a remote interlock box or emergency shutoff but other than that would you be prepared to be applicable for the VARIANCE FROM 21 CFR 1040.11(c) and the FAA.

Thank you for your time.

[allthatwhichis]

I am fairly certain it would be the same process as a projector with scanners; you just state what you are using and how. You just won't have "scanners" in the you product report and make a good drawing of you intended layout and effect on your show report.

[mixedgas]

The manufacturers report would be written more about the positioning system and some safety issues. The variance would just be "fixed beam effects" with a example configuration drawing.

You can run a show with fixed beams, the regulators do not care a whit about artistic aspects.

As long as it takes to get a report approved, I would rather do a whole projector or multiple models in one report.

Steve

[MLS]

Thank you for some clarification. One more quick ? if you don't mind on this situation.

Could one buy a >5mW (spec. http://cgi.ebay.com/Viasho-532nm-2W-...ht_2490wt_1160), hook the system up to an emergency kill system, apply for a variance w/ diagrams and get approved? I feel like it wouldn't because the lasers were not bought from a US vendor and not registered with the CDRH. I say this because I have heard conflicting stories about some not have accession numbers still getting variance approval in the USA. Sorry I've spend countless hours trying to find specific answers but have had no luck to most of them.

[allthatwhichis]

As long as you certify your projector to be CDRH compliant you can get anything varienced; the laser does not matter. It is the whole box they are worried about. That laser would be considered an OEM product within your projector and doesn't have to be certified before you install it; you will be certifying the whole thing. The seller is also a memer bere, "Frank".

[DanG]

You cannot get a variance for a projector which is not product reported whether or not the laser is being used with scanners. A diffraction grating laser does not often use scanners but still needs a product repot.

The report is the first step and you would submit your variance app at the same time. It is exactly the same as making a projector regardless of where the diode comes from.

[buffo]

Could one buy a >5mW laser, hook the system up to an emergency kill system, apply for a variance w/ diagrams and get approved?

You cannot get a variance for a projector which is not product reported whether or not the laser is being used with scanners.

As Dan said, you would have to file a laser product report in addition to the laser light show variance application. It can be done, but it will take a good bit of time and work to complete.

Many people use the term "variance" to refer to both the light show variance and the laser product report. This often causes confusion. The application form for a laser light show variance is only 2 pages long, but the laser product report is 34 pages long, plus whatever supporting documents you need (such as schematics, block diagrams, user manuals, quality control checklists, etc). Thus, while it may be fairly straightforward to file for a laser light show variance, filling out the laser product report is considerably more involved. It also takes a lot longer to get CDRH approval of your laser product report. (And you *must* have an approved projector with an accession number before they will issue you the laser light show variance.)

The laser product report is a large document that certifies the laser product as being compliant with all of the federal requirements. This document is normally filled out and filed by the company that builds the laser projector. Dan's company (X-laser) builds lots of different laser projectors, and he has to file a laser product report for each new design of projector. The document spells out everything that his company does to ensure that the projectors meet the requirements. This is why it's such a large document.

If you want to purchase a projector from a company like X-laser, then all you need to do is file for a laser light show variance. Under the section where you list the details of the projector you will be using, you simply insert the accession number for the specific model of projector that you will be buying. X-laser has already filed the laser product report for their projectors, so they have that information to give you.

However, if you build your own projector from scratch, or if you modify an existing projector, then you need to fill out your own laser product report and send it in to the CDRH. Basically, by building your own projector, you become a laser product manufacturer, and thus you are required to comply with the same rules that other companies (like X-laser) have to. Note that you can also send in your laser light show variance application at the same time, and once they approve your laser product report they will use that information for your laser light show variance.

If you've done everything right, when you get your variance approval from the CDRH, you will also have an accession number that you will need to label your projector with. This allows a future inspector to look up your projector's paperwork and verify that you've filed a product report and had it approved by the CDRH.

Adam