Recent content by masterblaster

Actually, it has a lot to do with me as an importer. I purchased a Class IIIa laser before. The factories name on the invoice did not match the factories name on the Accession number on file and the FDA seized the whole shipment. They sent a sample laser to the FDA in Washington for testing...

They have already given me the accession number and we had to instruct them how to format the label. I would like to know how I can validate the accession number before I approve shipment from China. We have been burned before when Chinese factories falsified information and the items were held...

Where can I search for a CDRH accession number to validate the exporter did in fact get one and the factory is correct? I do similar searches for UL certification and I can go to a web site to validate them. I need something similar to validate the accession number for a laser. Much...

Why is the reference to "5mw" significant?

I am purchasing/importing 3 gun scopes with red lasers. I am attempting to confirm they are FDA approved. They are class IIIa lasers. I helped them with the labeling. They cannot provide any testing data. They provided a document that the items are FDA approved and included an Accession number...

I have a green laser pointer class 3a. the FDA is requiring additional labeling. Can anyone direct to a template or sample label. I understand I need: The manufacturer, packer, or distributor, aperture, and date of manufacture. Thanks in advance.