FDA approval of Alpha series?

[Xplorer877]

OK so I got this Email from NOVA Lasers this morning:


----------------------------------
Hi Tony,

Thank you for your email.

For legal import into the United States under FDA regulations a >5mW laser must have a five-point safety feature system (aperture shutter, interlock, key switch, output delay and indicator LED). You can import and own >5mW lasers if they have these safety features for FDA approval. Our Alpha Series lasers do have these safety features for legal import into the USA.

We cannot guarantee that you will receive any product from us without hassles from customs as it is completely up to the discretion of customs as to when to inspect or hold a package or to contact the receiver. No company has any control over this. We do however have a delivery guarantee so should customs seize your package for any reason it will be re-shipped to you or we can issue a refund minus the shipping costs under our 7 day return policy.

Please let me know if you have any other questions.

Best Regards.

Magdalena Gudzowska,
Sales Director
NOVALASERS.COM
---------------------------------

I know that should the worst happen I can get my money back, but I still wanna be sure. The FDA states that a class IIIb laser must have the 5 point safety system thing, which it does, but it cannot be sold as a "laser pointer" to be legal. Plus Deal Extreme says on their website that there are new regulations being enforced, and they wont accept any laser pointer orders to the US anymore. :-/  

Has anyone bought from NOVA recently that lives in CA? How was it?

 

[thesk8nmidget]

yes you can buy from them since they are FDA approved

 

[diachi]

yes, They are 100% approved

-Adam

 

[Kenom]

yes, They are 100% approved  

-Adam

Uhh I donno how your coming to the conclusion that Nova has taken the time to get ascention numbers from the FDA for this model.  I read in the reply from Nova lasers that they are NOT FDA registered and you take the risk in having customs cease your laser since it is not.  They do however contain all of the 5 features needed to qualify for an ascention #.  It takes a lot of money to file with the FDA and for the Alpha, I donno if I'd want to pay that fee.  I think the proper question to ask Nova would be, not if it's got the features but if they did indeed file with the FDA for that particular model.

This is getting to be one of my pet peeves.  It's very easy for a company to say that thier lasers are FDA compliant.  Big woot.  Think that makes ya special?  Hell NO!  What makes ya special is ya claim FDA compliant and have actually taken the time to file for an ascention number.  Else it's just plain lying.  Good luck getting that laser through customs with no paperwork to prove it's truly compliant.

 

[pullbangdead]

[quote author=Diachi link=1225210474/0#2 date=1225211066]yes, They are 100% approved  

-Adam

Uhh I donno how your coming to the conclusion that Nova has taken the time to get ascention numbers from the FDA for this model.  I read in the reply from Nova lasers that they are NOT FDA registered and you take the risk in having customs cease your laser since it is not.  They do however contain all of the 5 features needed to qualify for an ascention #.  It takes a lot of money to file with the FDA and for the Alpha, I donno if I'd want to pay that fee.  I think the proper question to ask Nova would be, not if it's got the features but if they did indeed file with the FDA for that particular model.

This is getting to be one of my pet peeves.  It's very easy for a company to say that thier lasers are FDA compliant.  Big woot.  Think that makes ya special?  Hell NO!  What makes ya special is ya claim FDA compliant and have actually taken the time to file for an ascention number.  Else it's just plain lying.  Good luck getting that laser through customs with no paperwork to prove it's truly compliant.[/quote]

Correct. If they can't give you the accession number, or don't have one to give you, then it's not FDA compliant. The accession number is every bit as important as the 5 safety features in the eyes of the law.

 

[Xplorer877]

I'll ask them for the accession number on the Alpha series, but I doubt they will have one.

They never actually said they were FDA approved, they just said it had the safety features needed for approval.

I'm thinking that some percentage of their orders to the US are seized, then they just give refunds. How is it they get them through customs. This is pissing me off! I don't know if I should risk it.

 

[RA_pierce]

I and many others have ordered an X-series laser and it got through fine. I think you have a very good chance that you will receive your laser without any issues.

And, if not, you don't lose money because they will either send another one or refund the cost.

You'll be ok.

 

[Kenom]

I agree with Ra_pierce. Thier replacement guarantee is awesome. It's one of the main reasons this company will consider to stay on top at this forum!!!

 

[zachlr]

She says:

For legal import into the United States under FDA regulations a >5mW laser must have a five-point safety feature system (aperture shutter, interlock, key switch, output delay and indicator LED).

Not:

For legal import into the United States under FDA regulations a >5mW laser must have an FDA accession number.

 

[FrothyChimp]

It must have an accession number. The legal requirement isn't 5 point safety systems for import. It's the legal requirement to attain an accession number for a portable laser. If the import requires customs inspection it must be accompanied by an FDA 2877 listing the accession number. If it doesn't I'll guarantee the tariff code is not 901320 (lasers other than diodes) and it will be listed as some other "light" product.

 

[Xplorer877]

It must have an accession number. The legal requirement isn't 5 point safety systems for import. It's the legal requirement to attain an accession number for a portable laser. If the import requires customs inspection it must be accompanied by an FDA 2877 listing the accession number. If it doesn't I'll guarantee the tariff code is not 901320 (lasers other than diodes) and it will be listed as some other "light" product.

So what does that mean? Are they not providing the right # on purpose to get it through? Does customs think its just a light? :-/