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ArcticMyst Security by Avery

How to verify actual FDA approval?

Joined
Jan 12, 2012
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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.
How can I verify that these lasers are actually approved by the FDA?
I went to the FDA site and I don't see anything there.

Once verified, all I need to pass customs is the correct label and the actual manufacturers name/address on the invoice. Correct?
 





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Mar 5, 2012
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If it is FDA approved, it will have a bunch of safety features, such as key lock, LED indicator, movable shutter (covers the entrance of the laser when on) etc.

Hope this helps!
 
Joined
May 20, 2012
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I have a couple gun sights with the scope/laser.
If the are "inexpensive" sights with built in laser they are most likely 5mw.
 
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There are no laser pointers that are actually FDA approved with variance.....at least I have never seen one..... You can check for yourself at regulations.gov Just search for the company name, and if they have even submitted for a variance you can see it..... like this..... Regulations.gov
 
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Why is the reference to "5mw" significant?
If the laser power is above 5mW, is classified as IIIb and requires FDA approval and safety features, which are a key lock, mechanical aperture shutter, clear safety label, removable safety pin and most importantly, 5-second firing delay from pressing the button. Those safety features will happen on a gunsight when boobs start growing on trees.

If the laser is between 1-5 mW, it's classified as IIIa and does not require FDA aproval, in other words it's completely safe (well, relatively speaking. You're putting it on a gun :p )
 
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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 appreciation in advance.
 

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On the lasers manditory label along with serial number and other required information.

If the laser in doesn't have such a label with the accession number on it then probably it doesn't have one.

If the laser is not in your hands yet ask the supplier to read the label and email the number to you.
 
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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 by US Customs.
I need to make sure these accession numbers are valid.

Also, is it true if the lasers have a good accession number and the proper labels the factory does not need to provide test results to pass US Customs?
 

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As has been mentioned to you before there is not such thing as FDA approval of laser sights as such. Compliance with all FDA rules and regulations is not approval just compliance and has only to do with FDA and the manufacturer--nothing to do with you and US Customs.

Really you need to contact the FDA and get real answers to your questions about a specific product and specific manufacturer.

Here is part of a response from the FDA to one guy asking about laser sights--maybe it will give you some insight---the entire post can be found here: IR Laser Law - Response from the FDA - Page 3 - AR15.COM

"[Laser sights are subject to the provisions of 21 CFR 1040.1 1(b), Surveying, leveling and alignment laser products. This section limits this type of laser product to Class IIIa and a maximum output of 5mW. If they exceed the 5 mw limit they are required to comply with all applicable Class IIIb requirements which include an emission indicator, key switch, remote interlock connector, specific labeling and other features. Laser sights in the visible spectrum are limited to IIIa. If the manufacturer wants to power them above IIIa, they need to get a variance. IR lasers as surveying, leveling and alignment lasers are limited to Class I. To be powered above Class I as a laser sight, the manufacturer needs a variance.

Class IIIb aiming devices cannot be legally sold in the U.S. without a variance from the applicable requirements of 21 CFR1040.10 and 1040.11 having been issued by the Center for Devices and Radiological Health for such devices. It is our policy to restrict the sale of Class IIIb aiming devices only to the military, government and law enforcement agencies by purchase order for the procuring company.

An application for a variance may be made following the guidance found in 21 CFR1010.4 (b). A complete laser product report using the FDA's "Guide for Preparing Product Reports for Lasers..." must also be submitted.

CDRH issues to certain manufacturers, a variance from certain requirements of 21 CFR 1040.10 and 1040.11. The basis for approval of the variances is found in 21 CFR 1010.4(a). These variances apply to specific products and they expire and must be renewed. The provisions under which these variances are granted are specific; in certain cases they restrict sales to government and law enforcement agencies only, under a direct purchase order and under certain procurement procedures, as well as other conditions. Certain Class IIIb infrared laser gun sights and illuminators are restricted by variance for sale in the United States to Federal, State, and local law enforcement agencies only, and may not be sold to individuals. These products are intended for use only by agencies with safety training and property custody programs. Sales to individuals, no matter how well vetted, would effectively reverse the intent of these variances based on custody restrictions alone, creating secondary markets for these devices.

The regulations apply to manufacturers of laser products, not private citizens. I have recently reviewed all of FDA's active gun sight variances and we would not amend any variance issued to current variance holders to allow sales to private (non-government) firms or to individuals. ]"

Additional information concerning compliance of laser products may be found on the FDA web site: Laser Products and Instruments
 
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As has been mentioned to you before there is not such thing as FDA approval of laser sights as such. Compliance with all FDA rules and regulations is not approval just compliance and has only to do with tFDA and the manufacturer--nothing to do with you and US Customs.

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 (passed) but came back requiring us to relabel every laser.
They threatened to destroy the whole shipment.
That is what I am trying to eliminate.
 

Encap

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Actually, it has a lot to do with me as an importer.

I understand what your are saying an importer is considered a manufacturer---FDA definition is : Manufacturer (see 21) CFR § 1000.3 (n)) means any person engaged in the business of manufacturing, assembling, or importing electronic products.

All you can do as a buyer is ask the manufacturer if they comply and the item you want to purchase complies with all FDA rules and regulations and and do they provide all the documentation and correct labeling needed with a shipment for successful US Customs clearance and importation into the USA-- reiterate to them that they and the item must in comply in order for you to consider purchasing from them.

You could ask them to provide evidence that they and the product comply and that the shipping documents contain everything necessary but that is about it. While you can do your best to eliminate doubt, what actually happens happens and is beyond your control. Some days chicken and some days feathers with Chinese suppliers as everyone is well aware. You have no actual control over the actual manufacture/manufacturer in China.

Call US Customs and talk with a laser specialist about what is needed for a shipment to make it's way to you successfully or maybe ask Laser Compliance® Inc. - Regulations, penalties, and how we can help
Thier FAQs are pretty good, see: http://www.lasercompliance.com/faq.htm#regulationsanddefinitions

All the rules and regualtions and what the actual practices are can be a slippery slope as you apparently found out once before.
I would think professional expert help from people who know what and how to do like Laser Compliance Inc. is your best bet if all your questions are not completely resolved by contacting the FDA and US Customs.
 
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