Legal requirements and warning labels for a handheld Class 4 laser product

[Deadly Robots]

Howdy, people.

I've been doing some research for a project I'm working on. We're looking to bring a handheld Class 4 laser product to the market here in the US, and I stumbled upon this thread elsewhere on the forum. A lot of this information seems to be useful, but I was wondering how much of that info is applicable for a handheld device rather than a mountable one.

I'm also having difficulty learning exactly what sort of warnings would need to go on the product itself. The best I can find online so far is this PDF at LaserSafetySystems.com which mentions the need for specific wording, but I'm struggling to find anything more specific. Are there cookie-cutter warning labels out there? Would we have to design our own but make sure it includes the wordage?

You'll have to forgive my ignorance, here - lasers aren't really my area, I'm just doing the research. My apologies if I've mangled the terminology and so forth.

 

[InfinitusEquitas]

First of all... good luck :beer:

It would be nice to have another US based company sell class four lasers in the US.

There are several requirements you need to meet, in order to offer a class four laser, and these are primarily from FDA and CDRH. Without research, for warning labels here are several;

Warning Label must state;

Wavelength, Maximum Output, Class, Name and Information of the manufacturer, serial number and accession number.

Being a radiation emitting product, I would start my reading here if I were you...

Getting a Radiation Emitting Product to Market

 

[daguin]

The laser must have all five safety devices AND you must have an ascension number from the FDA

If you are serious about this, you should be working with the FDA instead of asking on a hobby forum

Peace,
dave

 

[Deadly Robots]

We obviously will be going to the FDA, but lasers are very much a new area for us. I've been asked to do the research, and this forum came up in a Google search, so here I am. I know nothing about lasers - you guys know much more than I'll ever know - so it makes sense to ask people who may have had experience in this area.

 

[InfinitusEquitas]

It's not a bad place to start at all, if you're starting completely from nothing, which I get the sense that you are.

What Dave (probably) means is that this is a hobbyist forum, and as such anything from here should be taken at face value, to require independent, and thorough verification. Especially where legalities are concerned.

 

[Deadly Robots]

I figured as much! So far this place has pointed me towards plenty of reading material so I'm on the right path, I feel.

 

[LSRFAQ]

I figured as much! So far this place has pointed me towards plenty of reading material so I'm on the right path, I feel.

You could read the docs all day, have a lawyer read the docs, and still not know what to submit. Its a poorly documented process and always has been, at least for the 20 years I've been on the edges of it. I have a product with the manufacturer's number and approval, and it was a long process 20 years ago. I have a friend that does it on a yearly basis, I help him with it, and the rules stll change. Its easier now..

In fact, avoid having a lawyer involved, this is a engineering process.

So having done it, the hard way, which is alone, I strongly suggest you
hunt down one of the more professional laser safety folks, who deal with CDRH on a daily basis.

You could start with my former friend Casey Stack...

Laser Compliance® -- Contact

Former, because we are on opposite ends of the planet now, my job, while still with lasers, requires internal, not external compliance, and I dont get to see him personally any more.

Casey seems to have a way of getting the paperwork through fast, simply because he does so much of it, and has had to defend clients in adverse circumstances. In other words, "He has the experience", and the phone numbers that still work. CDRH changes its contact proceedures constantly because it has to use FDA standard contractors to process some of the incoming mail. As contractors and staff change, the contact info changes often.

Then consult your l FDA Regional Electro-Optical Specialist.

They are the ones with Badges who come to inspect laser manufacturing facilities for "FDA GOOD MANUFACTURING PRACTICES", and can be very helpful up front. They are busy folks, have patience, because they are often on the road.


For the general public who read this forum...

Before some libertarian gripes "Government is for the people, and all should have the same access to regulators" that is not how it works in engineering related government, anywhere in the world. FAA, FCC, NHTSA, FDA, NRC, is a whole different legal ballgame then the constitutional law you get in high school. Technical interaction with the government is governed by Federal Code, and only a few specialist lawyers even have a grasp of it. So best to let a qualified engineering specialist or professional engineering society help you. This is not applying for a Dog license/Drivers license/Marriage Permit at the local city hall. There is not enough taxpayer money in the world to fund that kind of staffing for such a specialized matter. Nor should there be.

Steve

 

[Deadly Robots]

Cheers, Steve!