I have handful of display lasers from Opt, purchased several years back and used for home-tinkering only. They’re quite good for the price, one of the best from China, IMHO. Nice beam profiles, good performance from the galvos, nice color balance, well-built, and very reasonably priced. Since I’ve purchased from them, I receive regular communication. Today I received this:
Shenzhen Optlaser Technologies Co.,Ltd
We’re back to work after the Spring Festival holiday and ready for the new year.
I’ve attached our latest product catalog for you.
Great news for our US customers:
We can now support FDA Variance for any of our lasers, so you can use them legally in the United States.
If you would like to have the laser with FDA Variance, it’s just + $200 per unit.
If you’re interested in any laser model, feel free to let me know.
I’d be happy to send you a quote and talk more about the variance.
I haven’t dug into this, but if true, and legit, even with tariffs, it could be worth a look to determine if these represent a good value in the current landscape, especially for smaller shows and whatnot. Varianced lasers are also probably less likely to get held up in customs, I would assume.
You can buy the same laser for both prices , but one with paper version of variance document ?
from what i read from lasershowsafety:
“If you buy a pre-made laser projector, it should already have been reported to FDA, and received an “Accession Number” from FDA. This accession number is sometimes reported by manufacturers as a variance number since accession numbers often become variance numbers once FDA has approved a manufacturer’s submission.”
So basically you need only variance for operator. Then, i do not understand this 200 $ per unit when one paper for FDA is enough.
Some folks here are definitely more knowledgeable than I am on this, this is my understanding:
Anyone operating Class IV lasers in the US needs a variance for the operation of that laser. (We operators are considered a “manufacturer” of a laser display show)
Any manufacturer who wishes to build and sell laser display units in the US must have a separate type of manufacturer’s variance, authorizing the devices for sale. A separate variance is required for each model of laser.
To be granted that variance, the builder must show that the model meets safety requirements (safety interlock, remote stop, beam block etc)
Anyone can file for a variance - it is meaningless unless it is actually granted. It is a common tactic for Chinese laser companies to file variance paperwork, knowing it won’t be approved, and post it on their website trying to imply they are legal for sale in the US, when they are not. There is a way to look up approved variances, I need to go digging to find it.
So you as an operator need to be granted a variance, the laser itself needs to be granted its own variance. If OPT is for real, the $200 sounds about right for both doing the paperwork and for including the extra safety requirements that are necessary in the US but not anywhere else. Its the same reason why a lasercube from X-Laser in the US costs a bit more than one in the UK - X Laser does the builder variance paperwork and installs the extra interlock features in the units.
I am also not an expert (I’m a basement hobbyist), but my understanding is that there are two variances required for, say, a show (or multiple shows) with a single laser. The laser itself requires a product variance (meets safety standards), and then any public performance/show requires a variance specific to that show (ensuring safety standards on location), but I believe this can cover, say, multiple tour dates, so long as the show setup itself is not materially changing between locations.
I’m not aware of an “operator” variance requirement.
Just chiming in to share some info in case helpful as I’ve been on the manufacturer side of the fence for ~15 years
In USA, the the laser projector must have a product variance associated and product report filed for each laser family at FDA. That’s a long process in and of itself and many overseas companies are lying and state their accession “filing” number as the variance number then sneak them in as “stage lighting.” This shifts the compliance issue and liability to the user.
The way to know if they have received a variance is to ask them for the variance number ahead of time so you can look it up at Regulations.gov (enter it in that search box) and match it to the manufacturer and product ID listed in the approval letter pdf. IT’s important to look for the exact model family and name… that’s another trick they are using old variances for unrelated products.
We have even seen some take pics of other manufacturer variances and pass off as their own. The variance approval pdf you download from FDA will show clearly who is the owner and for which products it can be applied. The variance number itself should be on the manufacturer label affixed to the projector matching the manufacturer address, certification date and product ID.
The recipient of a Class 4 laser projector must hold a laser show variance before it is shipped from the manufacturer to that recipient. Varix handles this type of variance processing electronically and has a bunch of related variance info you might find helpful - and unlike some of the EZ style variances you can get that only applies to a single model, this type applies to all variances class 4 lasers you may purchase. Check their partners page sometimes you can get them for half off or even free. I hope this helps!