PDA

View Full Version : Sinjoe Lasers, Any USA owners?



daniel coyle
02-14-2016, 11:58 PM
Hello out there. This is my second post in an effort to get my new Sinjoe Laser through Customs/FDA in Seattle. They need an Accension number (which is apparently assigned by a division of the FDA?) The number is specific to model/manufacturer and so I am worried that Sinjoe has not been assigned this number. The manufacturer has both been on Chinese Holiday AND seems not to be clear on the number. Any one else who has successfully imported a Sinjoe machine?

Jerome Stanek
02-15-2016, 8:48 AM
Their holiday is over so you can contact them

daniel coyle
02-17-2016, 4:04 PM
Hello again. Hopefully someone will be able to help. I need the ACCESSION NUMBER for my new Sinjoe CO2 laser. The manufacturer did not provide it in the initial documents, I had no idea what it was at the time and my broker said nothing about it until the FDA said something. Now I haven't been able to get a hold of the manufacturer and the FDA said they will send it back or Destroy it if I don't come up with the number soon. Peter Chow is the name of the FDA guy, anyone know him? Anyway, just knowing that someone else owns a Sinjoe machine in the USA would be a step in the right direction as it would mean that Sinjoe has indeed been assigned such numbers before. Obviously, getting a bit desperate feeling here.

Bert Kemp
02-17-2016, 4:22 PM
Your broker should have that number or should be able to get it, also the MFG there holiday is long over now. If neither works I'd contact another broker explain your situation and ask for his help. Pay him if need be. better then losing a machine you paid for.

Bill George
02-17-2016, 4:34 PM
Found with a google Search > https://www.registrarcorp.com/fda-radiation/reporting/regulation.jsp?lang=en&title=requirements&gclid=COqpz5ff_8oCFQQEaQodPEcMtw

daniel coyle
02-17-2016, 8:17 PM
Thanks guys. I spoke with the FDA person today, Peter Chow, and he said that Sinjoe is not listed with the FDA and that hopefully they manufacture their machines with a partner or subsidiary that DOES have an Accession number assigned. Otherwise they will be rejecting the laser by next week. Not sure what that would mean ultimately, would it just get sent back to China and I could pay to have them re send after the Accession number is assigned or ??? He said this is somewhat common which was disappointing to hear. That there is no other solution the FDA has in place and that they see this happen not rarely seems problematic from a systems standpoint (of course it does when its MY laser that its happening to!) Anyway, if anyone has any other magic to offer i am all ears. Bert, thanks for the suggestion. I will follow up on that one.

daniel coyle
02-19-2016, 1:16 PM
Well, I got lucky. I had to get creative, and I have to leave it at that (PM me if you want specifics). I was able to send the FDA an accession number and an explanation about it that they accepted. Had I not pushed the envelope here in the way I am not describing I was promised by the FDA that the machine would be destroyed with no recompense. I had hired a broker that I had used in the past successfully and she did not know about accession numbers. I hired her because I did not expect that I could know and manage all the details of importing myself (thought I was being responsible and thorough by hiring an expert to handle it). This was a broker who was recommended to me on this forum. Of course I wish she had been more competent but she is my sense fundamentally responsible and reliable and after going through this it seems this part of the FDA's procedures is exceptionally challenging (understatement) for a small business person to negotiate and very easily missed by all but the most specialized/experienced brokers.

Some manufacturers have these numbers and some don't, the FDA does not share the ones who do and don't (which is unhelpful to say the least), the manufacturers who don't have this number may or may not know they need it and there is no barrier to them making the mistake of sending a machine without it. What's more, that there is no other process in place by the FDA but to destroy machines that don't have the number is bleak.

The accession number is assigned by the FDA to Chinese companies after they fill out a form stating that their machine is radiation safe. The FDA may or may not inspect that company later and validate the claim. So, the accession number is often a "safety guarantee" by the FDA that was policed, essentially, by the Chinese manufacturer whose primary interest is selling machines and not safety of international users.

That the FDA doesn't offer to make one pay for an individual inspection or even a fine of some sort while giving one the chance to prove the product's viability is really minimalist and does not address the complexity and vulnerability that already makes up the import process.

I say this all so that, should someone else be looking for advice or feedback, they will hopefully find this and be better prepared to avoid this potential cliff themselves. I feel extremely fortunate to have gotten out without loss but if you heard my story you might be surprised that I did. I may be missing something here, in fact I am sure I am, and I am happy to hear any feedback. Obviously I am biased after going through this and would probably not even have looked at a thread like this had it not been my problem (so, thanks so much to those of you who offered time to help out.)