[mas63]

Just wondering if anyone else has experienced these problems when importing a laser from China

The FDA as taken the machine and requiring some sort of Product Report, from the manufacturer and if I do not provide that in 10 days the machine will be destroyed.

I am getting a little afraid I may have lost my money and machine, I am sure trying to get the money back from the company will be a losing battle.....

mas

[Aksess]

What company did you order from? Beware China lasers are junk and worth about half or less of the price they ask.

[mas63]

Jinan G.Weike Science&Technology Co.,LTD.

I realize the quality of chinese laser is lower, howerver I only need it to make stamps, I could not see spending $15 to $20 thousand just for stamps.

mas

[kreutz]

Mas63;

Why is the FDA interested in your machine? Are you importing it as a medical device? Otherwise I don't see how would they have to be involved.

[mas63]

THe way I understand it, because the invoice had the word "laser" on it, it thru up a red flag, now they are claiming something about a radiation statment.

[kreutz]

You probably only need the manufacturer's statement about the power output, laser wavelength, and Class. I still don't think this is under the jurisdiction of the FDA. Probably the equipment does not have a visible label with this information and the word "Caution"

[bml6116]

..since I work in the Pharma industry, let me add my 2 cents:

In terms of equipment, FDA only has regulatory authority over devices used in medical practise and food stuffs. So, for them to get involved, that equipment may have been labeled as a 'medical device'. I think if you add statements that explicitly state that this equipment is used for manufacturing (for whatever),
NOT for medical diagnostics, NOT for preparation/manipulation of food stuffs, NOT for human use.

Cheers,
Bernhard

forgot to add 'NOT for Drug Substance or Drug Product Manufacture'

[wklaser]

Hi, USA clients please contact directly from our sole agent === brightstar company, they will give you great support and 2 year warranty for all the parts of the machine.

website:
http://www.brightstarlasers.com

[yamingf]

the manufactuer should have certificate from US authorities

[wklaser]

The FDA certificate is very important for US market at present. We have ever send a laser machine to USA without the FDA, in result the goods was impounded in the custom. The officer of the US custom told us that there are only 2 ways to solve the problem. first one is to destroy the goods by them, the second one is to return the goods to us by FedEx, but the high delivery cost is cost by us.

So, friends from US who are preparing to buy laser machine must make sure that you, or the supplier(manufacturer) must have the FDA certificate in hand, otherwise you will lose a lot and will get nothing, except wasting your time.

Just an suggestion, take it or not, it's up to you.

Regards
Jack


By the way, We have an exclusive agent in USA, they can supply you excellent service and professional support. They will give you 2 years warranty for all the parts of the machine. If you want good products with low cost and great service, please contact them:

Attn: Jim Olsen
31220 Hilltop Blvd.
Running Springs, CA 92382
(909) 936-5554
Site:www.brightstarlasers.com

[ivirscar]

Mas

Simply file a chargeback on your credit card. I'm sure you DIDN'T do a bank or wire transfer... When I purchased mine from China, I wasn't sure of what I would be getting so I insisted on using a CC to be "safe"