US FDA certified lasers?

If I remember correctly, it is FDA approved.

yeah the RPL is FDA approved.

Artix said:

[quote author=Diachi link=1220158725/0#2 date=1220179310]The RPL from optotronics is FDA approved, it's a real solid laser, and doesn't heat up, has loads of great features.

www.optotronics.com

Click to expand...

Wait... The RPL has only an aperture shutter... :-/ Maybe you where thinking of the Aries?[/quote]
I believe it also has an LED indicator.

I don't mind the Chinese coming here to push their products. What I mind is when they come here pushing crappy products that cost 2-3X as much as their dx equivalents. If reps from CNI or Viasho were here trying to sell their goods it wouldn't bother me as much. Instead we have warnlaser spammers and spymodex/dx resellers looking for some quick money.

What do you need to make a laser FDA approved?

Theres 5 i believe
1)key
2) aperture shutter
3)indicator light
4)interlock
5)output delay

john_lawson said:

Theres 5 i believe
1)key
2) aperture shutter
3)indicator light
4)interlock
5)output delay

Click to expand...

It doesn't look like the RPL has all five. :-/ I may be wrong...

Yeah, but they are FDA approved so somehow he got them passed...

Yeah Viasho got the accession number for the hand-held units (RPL, Prometheus, etc). No Idea how... they only have three out of the five safety features. Key, aperture shutter and emission indicator. Maybe since the button is click on/click off it could be considered an interlock, but either way it doesn't have a delayed output.

Guys...you should ease off on Standstone11.  She has been selling nice products at a very reasonable price.  If her "FDA approved" version is less then 1/3 the cost of an equivalent US sold item, then I'm excited about the item.  This is what is known as competition...and may cause the US laser carriers to lower their prices to increase their sales.  In addition, 90% of the items these US companies are selling are from the same Chinese manufactures with slightly different specs.  Unfortunately, you also get what you pay for.  But sometimes this may not be true.  There are a lot of greedy US sellers.  So I say...give Standstone11's product a chance and until it is proven to be junk (which it hasn't) I welcome her product

Her website with a price list is here:  http://hi.baidu.com/colorlaser/album

In addition to the safety features mentioned above, you need to submit your lasers to FDA for approval. This process usually takes several months. Once approved, FDA will assign you an accession number. To be sure the laser you are about to purchase is FDA approved, ask for an accession number and have them show you the paper work. There are actually companies out there that can help you with the entire process.

A laser does not have to have all five safety features to receive an FDA accession number. If any of the features are missing, a justification must be made as to why. The FDA then decides whether to assign an accession number or not. I've seen laser systems approved without aperture shutters but that's really about it.

Both CNI and Viasho produce portables that meet all five safety requirements. I believe that S-KY also now meets those requirements. What is actually shipped may or may not be the same laser that the accession number belongs to. For example, if a portable is shipped with a different tail cap that defeats the interlock then it is considered a different laser and should not be shipped under the existing accession number. Of course, this may not prevent it being shipped as the FDA inspection by customs will not know the difference if the package is opened for inspection because they do not operate the laser system when inspected. This is how many systems arrive in the U.S. without all the safety features intact.

We distribute for many laser manufacturers but we never order anything less than the accessioned laser system. We do not need the liability that comes with that. The only time we alter a portable is for the military as they do not fall under FDA requirements and that's only if they request it.

U.S. distributors of lasers do not need an accession number as long as the laser system was imported under one. If the laser is altered after arriving then the distributor bears the sole responsibility, from a legal perspective, for the alteration and any damage or injury it may cause. Any lasers manufactured in the U.S. must register with the FDA for each and every model of laser. The FDA is pretty brutal when it comes to enforcement. If a U.S. manufacturer is caught selling non-registered lasers they will fine the violator for each and every laser sold, they will require the manufacturer to recover every laser sold and refund the money to the purchaser. If the violation is significant they can also bring criminal charges.

It doesn't mean s@%t if they say they are approved by the FDA. Ask for the accession number!