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FDA Approved Companies


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^While I can't say for sure without actually seeing the FDA paperwork/accession numbers for each laser on that site, I would be VERY surprised to hear that any of those lasers are actually FDA approved.
 

daguin

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The FDA doesn't approve "companies." It regulates products.

Having an accession number does NOT mean that the product is approved. It means that the company has sent an application to the FDA.

If the FDA finds/discovers reason to believe that the company's reported specs are not correctly listed in the application, it then asks for proof of the testing protocols at the company.

If the company either does not provide answers or their answers are found to be false, then the FDA will disallow the import of a product or products. It can also prohibit the import or sale of any products from that company, require the recall of the products, and levy fines.

In order to "know" that a particular laser complied with FDA regulations, you would not only need to know the requirements of the FDA, but you would also need to find the accession number AND search to see if there were any warning letters from the FDA to the company. You would also need to look through the prohibited companies list

Fortunately for us, when considering hand-held lasers, you really only need to look for the five safety requirements to know if a laser is "legal" or not (key lock, delay, emission indicator, integral aperture cover, and power dongle)

If it is missing one of those, it is not FDA approved ;)

Peace,
dave
 
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Fortunately for us, when considering hand-held lasers, you really only need to look for the five safety requirements to know if a laser is "legal" or not (key lock, delay, emission indicator, integral aperture cover, and power dongle)

If it is missing one of those, it is not FDA approved ;)

Peace,
dave
Welcome to the murky, convoluted world of CDRH regs! lol..

While the above is a great way to be sure that the laser is *potentially* legal, there is specific paperwork that must be completed by a company before the FDA/CDRH will allow the device to "enter commerce", which in this case means devices being sold publicly. Simply having the required features in and of itself does not mean that the laser is legal. It must be certified as being so by the FDA.

For my own business, I'm fortunate to have a business partner that is well versed in FDA regs.. I'm learning from him, but there is still some areas of confusion for both of us. Good luck getting a straight answer from the gov't entities themselves.
 

Justin

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One good way to check out a product's legal status is to get the accession number from the seller, then contact the FDA/CDRH directly to ask them if the accession number matches the product that you are trying to purchase. If you don't actually check the accession number with the FDA, then a dishonest seller could simply give you any long string of numbers and claim that it was a valid FDA accession number.
 

daguin

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While the above is a great way to be sure that the laser is *potentially* legal, there is specific paperwork that must be completed by a company before the FDA/CDRH will allow the device to "enter commerce", which in this case means devices being sold publicly. Simply having the required features in and of itself does not mean that the laser is legal. It must be certified as being so by the FDA.

I was focused on the opposite end of legality. My point was that the VAST majority of lasers that the "average" NooB here is asking about are NOT legal. Most of the lasers that are asked about here do NOT have the required safety features. If they want to know if a laser that they are looking at is "legal" and whether the seller is truthful, all they have to do is look to see if the laser is missing any of the required things. Most of them do not.

IF the laser has all of the required components, THEN they would have to look to these other means to see if it is actually legal. It is easy to see if it is illegal. It is harder to see if it is legal. Sorry for the lack of clarity.



One good way to check out a product's legal status is to get the accession number from the seller, then contact the FDA/CDRH directly to ask them if the accession number matches the product that you are trying to purchase. If you don't actually check the accession number with the FDA, then a dishonest seller could simply give you any long string of numbers and claim that it was a valid FDA accession number.
We had some people trying to look into the Arctic's accession number. They were told that information was not public :undecided:

Peace,
dave
 
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We had some people trying to look into the Arctic's accession number. They were told that information was not public :undecided:

Peace,
dave
Im not sure about accession numbers but most any fda/cdrh paperwork should be available at regulations.gov

example: You can search for any of Mark's(GotaLoveLasers) (aka CT Lasers) fda paperwork by searching for just company name "connecticut laser-tainment"(withought the "-")

Hey Dave.....why is "lasertainent"(spelled wrong here) censored in forum software?
 
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daguin

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Im not sure about accession numbers but most any fda/cdrh paperwork should be available at regulations.gov

example: You can search for any of Mark's(GotaLoveLasers) (aka CT Lasers) fda paperwork by searching for just company name connecticut *************
Yeah. I wasn't the one doing the research. Dim recollection is that one of them was Tterbo or Twhite (or T something ;) ).

Maybe the FDA employee was just doing what they needed to do to get the guy off of the phone :(

Peace,
dave

**EDIT** Hey Dave.....why is "lasertainent"(spelled wrong here) censored in forum software? -- Sorry. I haven't a clue why. Send an email to Avery or ask in the Admin board
 
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Justin

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The accession number has to be printed on the warning label for the laser to be compliant, so I can't think of a good reason why a company wouldn't share this information with a prospective customer since the information is already more-or-less in the public domain. Well, I can think of a reason, just not a good one.

We often have purchasers from government labs and universities who require that we send them the accession number of a laser before they'll even buy it. (I presume they check it with the CDRH.) Before they get approval to buy something of such high value they need to prove that the product will be legal for import, so I totally understand where this regulation comes from. If a laser seller doesn't want to give you the product accession number it's probably because they don't have one, or they know that if you check it with the FDA it'll turn out to be bogus.

Of course, many people are simply not concerned with the legal status of their imports so I suppose this only applies if you care about such things. Daguin's point about most handheld lasers being obviously non-compliant is also quite valid, since the accession number is a moot point if you don't see any safety features on a Class IIIb laser.
 

Trevor

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Dave, you're correct, that was me.

I spoke with someone on the phone who, if my memory serves me right, was a safety officer in the CDRH. I'll grab the contact information off my work computer when I get a chance.

When I spoke with him, he seemed confused as to how I had this accession number, and could not (or as Dave said, would not?) reveal anything more to me, citing that an accession number is something like a case number, and is meant to be confidential.

EDIT: I just checked - he's a "Consumer Safety Officer" with the CDRH. I could get back in touch and inquire further if anyone is actually interested. :)

He might have been confused about what I wanted (unlikely), wanted to get me off the phone (more likely... but the conversation was initiated after I had left him a message and he called me back), or usually deals with businesses who know the system better. At any rate, I'm going to defer to Justin's experience with exporting lasers to the United States. ;)

He did, however, reveal that they were aware of the Arctics at the time. :p

-Trevor
 
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hakzaw1

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A more important bit of info may me the, IIRC Customs/HLS , "trusted seller/shipper list' or the 'not trusted' one. If my understanding is correct once on the good list they pretty much leave your packages alone and vice versa. This info may very well be not public. I got most of mine from AixiZ- a trusted shipper.

hope this helps and anyone with more about it is welcome to add it.
TY
hak
 




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