ATT: Foreign Laser System Manufacturers!

[gottaluvlasers]

I feel, at this point I need to make a public warning and also, vent a little bit.

1) EVERYONE in the Laser industry around the world and ESPECIALLY *ALL* Laser manufacturers on this forum know DAMN WELL about the laws, regulations and restrictions of Laser products over here in the USA. And just in case you don't or just to sum up, Here it is...

No Class 3B, IV or demonstration Laser product of *ANY TYPE or MANUFACTURER* may be sold to, transferred to, given to, lent to, sent to, shipped to, dropped to, provided to, rented to, leased to ANYONE or ANY firm in the United States without A) That product being certified under 21 CFR Part 1040. B) The user or importer have a Laser light show variance. C) If foreign Laser manufacturer does indeed have product certification then product must then be sent to their USA importer, record keeper and quality assurance director PRIOR to being sent to the end user (customer).

2) If you are a foreign Laser manufacturer of ANY SORT (Hobbyist or professional) and are pricing out or trying to sell projectors over here in the USA and are telling your customers, "Don't worry the laws are stupid and your odds of being caught are very very slim" you are #1) lying directly to your customers. #2) Are being a VERY irresponsible business. and #3) quite simply a pretty pathetic person/business gambling with your customers hard earned money.

3) Foreign Laser manufacturers (and people here that think the following)...it *IS NOT* "ok" or "within the laws" to import a Laser projector that is not certified and varianced here in the U.S under ANY CIRCUMSTANCES. Whether you plan on using said projector in commerce or in your basement. A Laser that is imported and in any way transferred to an individual without product being certified and varianced is breaking the law. It *IS NOT* the same as if product was designed and built over here and then transfered to someone else over here for their own private use in their home. In THAT situation, there is an acceptable "grey area" where commerce does not apply and therefore, certification and variance is not required as it is being used privately.

When a product is imported from a foreign manufacturer the seller *AND* the receiver can be held responsible for the product being shipped and imported illegally.

In the past few months I have had at least 5-7 customers call and ask me to "price match" foreign manufacturers and companies (a few of which are represented on this forum) for certain Laser projectors and/or laser projectors which match foreign laser companies specs. I asked these customers how they plan on importing and using these systems which they received prices on and are were quite perplexed when they found out that not a single one of those foreign companies explained the USA certification and variance regulations. Another 2 customers explained to me that the sales people they spoke to at the foreign companies simply said, "Dont worry about it. nothing will happen." Thats a pretty shitty atitude to have with a customer of yours that is giving you some serious amount of money!

Most recently was yesterday. I sold a cusotmer a projector after quite a few days of speaking back and forth. The customer originally spoke to a different company outside the USA who never told him about the certification issues and never told him about the variance issues. This customer would have been stuck with a $20,000 Laser system that they couldnt use.

For those companies or individuals who build systems and attempt to export them illegally to the USA, please realize that you are doing yourself and your customer a disservice.

From this point further, myself (CT. Lasers) and quite a few other companies will be informing the CDRH of *ANY* foreign laser company or individual who attempts to sell a projector over here illegally and without fully informing their customer(s) of the Laser regulations required here in the USA. A few of these companies are active on this forum and should heed the warning.

This has NOTHING to do with "competition." In fact, its just the opposite. I (and many other companies) WELCOME a *LEGITIMATE* and level playing field of competition. I am involved to an extent of the certification of the KVANT systems over here. THEY are competition for me. I make much more money on selling my own systems, but i see the value of the KVANT systems and they make a beautiful, quality projector. So, there is a market for them over here. I have PERSONALLY turned away probably at least $100,000 in KVANT projector sales because they ARE NOT *YET* certified over here. Therefore there should be NO foreign company trying to sell them over here (unless you do your own certification and variance. when, in that case- be my guest!)

Do the right thing. Period. Laws are in place for a reason. you may not like them, they may seem silly to you, but they *ARE* there. The tides are changing over here RAPIDLY. And quite honestly, im sick of losing business because of arrogant and "i dont need to follow the laws" foreign laser companies.

-Marc

[kiyoukan]

Sorry if this is a thread jack but those all apply to end systems correct?
If you are selling lab lasers to go into a system we dont have to follow any of those rules correct?
They just apply to end product such as a projector need all those certification's not each laser that was built inside.
because they are not a "demonstration Laser product" they are a OEM component to be put into a end system correct?

[mixedgas]

Sorry if this is a thread jack but those all apply to end systems correct?
If you are selling lab lasers to go into a system we dont have to follow any of those rules correct?
They just apply to end product such as a projector need all those certification's not each laser that was built inside.
because they are not a "demonstration Laser product" they are a OEM component to be put into a end system correct?

----------------------------------------------------------------------- END QUOTE--------------------------------------------------------

OEM manufacturers are NOT supposed to to do "Over the Counter Sales". I know of one OEM that had to confirm every OEM DPSS laser it ever sold to academic and some industrial customers was retrofitted with a keyswitch, a emission indicator, and the stickers. I know, I got the memo, and installed the retrofit kit at my former academic employer. Hundreds of lasers needed retrofitting and documentation.

Lab lasers and Industrial lasers have manufacturing controls. This requirement does not apply just to laser show projectors. The "no delivery" thing is more or less specific to display lasers.

There is one exception I know of. Small laser pointers, CLASS IIIA,(under 4.95 mW) have a blanket exemption, provided they have a Class IIIR warning label and a stadardized labeling on them. Everything else, including CD players, etc has to have manufacturing controls and paperwork submitted. Lab lasers coming in from China where the import paperwork and certification has not been done, are ILLEGAL, period.

Now dont get the idea that you can dial a laser down to 5 mW, and then publish the instructions to dial it up to a watt.

OEM does not get you out of the woods, OEMs are required to keep sales records for SEVEN years.
OEM is supposed to get a sticker saying OEM LASER PRODUCT FOR INSTALLATION in a blah blah blah ONLY by a approved...
OEM manufacturers are NOT supposed to knowingly smile and skip around the regulations.
If you sell a kit, its still a product if it can emit coherent light.

I'm not tearing apart my HENE that has said required sticker on the tube to quote it exactly..
I've also seen said "OEM ONLY for incorporation in a approved product" sticker on raw diodes I've bought.

I am aware of one gentleman who faced a tremendous legal battle for selling OEM hene power supply KITS without tubes. His company had 40K in legal costs, they negotiated the fine down to 8K.
This was 10 years ago, but enforcement does happen.

I have two DPSS in my basement that were part of a legal liquidation sale soon after DPSS green was unvailed for low cost sales. The manufacturer skipped all the approvals and evidently got caught.
I had to send a copy of my vari # to the reseller/liquidator to get the units, and sign a agreement that I would only use them in the approved projectors.

Attempts to get the CDRH to clarify what a hobbyist product is and what a OEM product is, have gone unanswered, even when submitted in email, through ILDA.
I know, I asked for the question to be answered, and so did some very prominent other PLers. We asked specifically about repuposed laser diode modules, and a general question on diode drivers as well.

As of last year, I had to sign a no-resale/reuse OEM agreement to get samples of a high power red diode. If that companies lawyer thinks its important enough to comply with, then there must be something to it.

A safe assumption, is if you are selling more then one item on a advertised or commercial basis, you are legally a manufacturer.
If you are importing something that emits coherent photons, even a raw diode, you are a importer. Unapproved lasers are only supposed to be imported for testing and then destroyed or returned to country of origin. There is a laser specific import form to be filled out and sent to DC for approval before import.

Enforcement is selective. That does not mean the law is not enforced. Nor am I a lawyer, so you can take what I say with a grain of salt.



Steve

[kiyoukan]

So i am building several red 635nm laser setups and offering all the parts to build them.
Should there be anything i should be doing when selling or building to keep things legal?
By the sounds of the system its almost 100% impossible for any small time member to even climb that mounting with out a large amount of capital to secure all of the right permits and legal fees of the lawyers.
Im just looking to sell a simple 635nm build and maybe a dual and quad kits and even bare diode's.
I have read alot of the articles but they all seem to leave the space i think i occupy in a gray zone with nothing very certain.
I love to build and experiment and test lasers but i want to do it safely, and the info just seems to be setup to confuse anyone who is not a lawyer.

[dsli_jon]

Heya Chief -

110% with-ya, on the 'responsibilities of manufacturers' and, how they're 'defined', but a couple thoughts, and a 'clarification'...

No Class 3B, IV or demonstration Laser product of *ANY TYPE or MANUFACTURER* may be sold to, transferred to, given to, lent to, sent to, shipped to, dropped to, provided to, rented to, leased to ANYONE or ANY firm in the United States without A) That product being certified under 21 CFR Part 1040.

..*EXCEPT*, under the strictly-conditional, and exclusive-provisions of the FDA-2877... Here's a bit of chatter / clarification about 'under-what circumstances' a full-fledged PJ / turnkey-laser module / head, can-be 'imported'... http://www.photonlexicon.com/forums/...909#post192909

...otherwise, it would be impossible for an 'importer of record' to ever apply for certification, if they could not, for example, actually-physically 'QC' all the safety-components, they were 'testifying' are safe / compliant.

..but, as you say, that is *NOT* any sort of 'blanket' for a foreign-OEM to start peddling / selling / shipping, like oh-so-many ChOEMs and others, LASERWORLD do... Additionally, as you say "B) The user or importer [MUST] have a Laser light show variance. ", not just the 'please take a number / get in line' Accession-number of-having applied...

3) Foreign Laser manufacturers (and people here that think the following)...it *IS NOT* "ok" or "within the laws" to import a Laser projector that is not certified and varianced here in the U.S under ANY CIRCUMSTANCES.

..Again, except for-those exclusive, *conditional* provisions of the 2877... which is a very-narrow 'window' / provision...

It *IS NOT* the same as if product was designed and built over here and then transfered to someone else over here for their own private use in their home. In THAT situation, there is an acceptable "grey area" where commerce does not apply and therefore, certification and variance is not required as it is being used privately.

That's a reeeally-tricky 'line to walk', tho, mon frere.. For example, the whole 'foundation' of a certain 'ProDJ' we all know and luv 's 'defense', was that, 'he was only using this [his 40W pulsed-laz0r] at his house' / for "private-use" - thankfully, he is (apparently) on the 'right track', now, because his 'attitude' was, 'well if I just put up a SIGN and warn everyone they might be exposed, it's ok...' MG-ignorant / stupid-rationale, especially for the laser he was using...

..Point-is, that 'private-use' caviat *STILL* does NOT-EXCLUDE someone from knowing / practicing the safety-principles-involved, and that, the knowledge of both the actual 'letter of the law', and the 'spirit' of it, is 'Passed-on', from Manufacturer, to end-user... NOT, imo, a 'place for n00bs to just-go'.. THAT'S why, I, for one, am such a 'nut' about pointing-people to the 'safety-Wiki' - at-least READ / know / understand the 'Regs' - even-if you'll only-ever be 'working in your house' - because NO ONE ELSE IS TELLING THEM, about that mission-critical information! The 'ChOEMS' sure as heckfire don't tell them!!

..and how many times have we (the community) seen the 'OMG'-videos of some 'start-up', multi-watt scanning the living-cripes out of someone in their living-room, or - even themselves! It's NOT about pushing-Regs or Guv or playing 'lasercop', it's just about spreading the EDUCATION.

..Ya know - if just EVERY-SINGLE OEM, out there, were to even-just distribute - prominently along with their 'component sale' - that simple, yet very-informative / pretty-comprehensive, "Laser Safety - Who's Responsible" PDF from the CDRH?? How much greater would the 'knowledge-base' be, in this Country?? I'd say, a LOT... Well, yes - that's also assuming people still READ...

I have PERSONALLY turned away..KVANT projector sales because they ARE NOT *YET* certified over here. Therefore there should be NO foreign company trying to sell them over here

Agreed, however - As I recently posted, and can't find for the life of me (cuz VB's search-engine SUX moose... - The US 'Importer of record' HAS-GOTTEN - according to them - "verbal approval" on the 5W-class, and up, specifically, the 15W models they submitted... This DOES NOT-MEAN, that 'all Kvant products / PJs are 'now-approved'!! Each Kv PJ out there still must-be compliant, with the specifications of the certification, and that Certification is for what Models that Co. filed-for, ONLY. Lower than 5W-models, have a different chassis / layout, and MUST BE BROUGHT INTO-COMPLIANCE / SUBMITTED on their-own, for consideration of being 'amended' to that PJ-lines' approval...

..Which, btw, is NOT FOUND under "Kvant" or "Spectrum" or any-other of Kvant's brand-names.. Meaning, if you apply for a Var - or 'amend' your existing - with 'Kvant XYZ', it will likely get-bounced / they won't 'find it in the DB'...They will be known as the 'Spectrabeam' PJ-line, under-which existing-approved-PJ line, they were filed... I don't feel it's my-place to go posting that Co's Variance / info - 'public-info' or not - but you can find info about the Co, in the Fed Register, and call them up / inquire about their 'status' if you like, yourself. They said they were 'still waiting on the final sign-offs' / hard-paper, etc - which was a month + ago, so.. for all I know, they might actually have the paper, by-now... Anyhoo, that's what I know..

---
heya kiy..

So i am building several red 635nm laser setups and offering all the parts to build them.
Should there be anything i should be doing when selling or building to keep things legal?

READ and STUDY the Regs, specifically-for 'OEM Lasers, as-components'.. as Steve-said, there ARE SPECIFIC COMPLIANCE-REQ's... BUT, they are NOT nearly as 'volumniferous' or difficult - or expensive - to achieve, as you might think... You can go the 'easier route' of simply not SELLING and actual LD.. However, even if you go selling a 'laserless-kit', you STILL have the responsibility to 'pass on the knowledge' of the requirements to the end 'Integrators' of your product, and comply, to the degree 'relevant', for your kit...

ie: If all you sell is 'metal parts and optics', no power-supplies, no LDs, at a *minimum*, you would also want to include the 'proper labels', on the enclosure, etc.. ie: Classification, Warning, Aperture, OEM-component 'disclaimer', etc, etc.. 'Deeper-level' requirements (ie: Emission-indicator / keysw, included - required, or not?) will depend on 'how OEM' of a kit you will be selling.. ie: Is it designed, once assembled, to be capable of 'tabletop' / standalone operation? Then, more than 'labels' will be required. Steve and or other seasoned OEM-integrators, can be a great-help to you in that regard...

By the sounds of the system its almost 100% impossible for any small time member to even climb that mounting with out a large amount of capital to secure all of the right permits and legal fees of the lawyers.

NO 'laywers' are needed - this IS all stuff YOU CAN DO! There are several PL-members that have 'hiked this trail' and can steer you straight.. I'd love to help, but I'm already 10x oversaturated for one person, but... I love to help, when / where I can.. Like I said - the 'ChOEM's aren't gonna 'tell you what you need to know', ya know? Which, imo - even on a 'component-level' - they should..

ciao for now..
j

[gottaluvlasers]

^^ Jon-

Good points. However, i was purposely trying not to "touch" on the "very narrow" fields of acceptance because we all know that NONE of these foreign companies except RGB Lasers (Themselves) and KVANT (themselves) have ever done this practice. I was trying to keep this as to the point and direct as possible. Of course there are grey areas and "acceptable exceptions" to almost any situation. But the 99% that this original post was directed at do not intend on doing ANY legwork.

Yes- there are quite a few KVANT systems out there that are certified. However, these were "one off" certifications. The importer(s) modified and in turn certified the system(s) as some sort of different system. The 5W KVANT I dont *think* (i may be wrong) is certified as a whole model family.

The scope of this post was to start to deter some of this practice. There are always exceptions to *ALL* rules. You cant bring dynamite on a plane. However there *ARE* some very strict and conditional situations where this is allowed. However, 99.9999% of the people will NEVER do the legwork to do such a thing, (ok, maybe an exaggeration. But you see my point).

Yes, if you are "Joe Smith" who wants to import "XYZ" to certify here and be their keeper of records and importing agent, than there are certain provisions that are allowed.

As far as OEM *MODULES,* no, i am not implying that this post applies to those. Thats a different ball of wax. And I (nor almost anybody else) have no issues with the sales of these. As these are just components that go into an end product that *SHOULD* be handled and reported properly.

-Marc

[dsli_jon]

Hey Mon -

i was purposely trying not to "touch" on the "very narrow"

I was just taking the wind out of the sails of any of the 'Yeah, but...'s..

However, these were "one off" certifications. ..The 5W KVANT I dont *think* (i may be wrong) is certified as a whole model family.

Mmm, that's not what I really meant.. Again, though, they were Certifying the 15W 'chassis' - (their submission was all-based around a 'chassis'-size and what will fit / can be used, as a 'class' / family).. I believe that's what they were really 'saying' - that 'chassis'-size / layout, with anything from 5W up-to 20W, was being submitted.. That's what I was told was being Cert'd, not 'Kvant's-definition' / model of a "5W"... These won't be called 'Kvant-anything', stateside... but they are, 'under the hood'..

..And, as I said / am-reinforcing your point, NO, this does NOT 'automatically-mean' that 'all Kv's are Cert'd' - nope.. Each PJ, already out there / intended to be-imported, must be brought into-compliance, with the specs-specified in the certification... (ie: hard-shutter, emission LED, etc..). Anything 'outside' the realm of those specs (ie: a Kv 2W or 3W or etc...) will have to be submitted / get-approved, by each owner..

However, because the Importer, here, is-wisely 'putting the ownice' on Kv, to 'make / incorporate the mods', that's good-news for all future-intended US-side buyers, much like is the case with the RGBs from Hungary... once Approved, they will 'land', compliant. But, again, as you stressed, this is NOT a 'blanket', and yep - others need to wake up... or get woken-up...

Cheers to your efforts, with ya all the way, Champ...
j

[mixedgas]

QUOTE:

I love to build and experiment and test lasers but i want to do it safely, and the info just seems to be setup to confuse anyone who is not a lawyer.

END QUOTE

I've yet to meet a lawyer who understands laser safety compliance. Most lawyers I've asked would bluster and try to find a exemption to doing the paper work, or simply not take the case and refer you to a specialist.

Thus this paperwork is usually the realm of a engineer or technician. Last I heard, the best guy in the biz would charge you between 500-900$ for what you want done. Thats peanuts for a specialist. Its a fraction of the cost of a lawyer.

FDA used to explain this by sending out the massive "laser safety packet", then some one got cheap and decided it had to be faxed. Then a limited subset was on the web. Now I dont know where you would get it. If I ever find mine, I might just scan it in. I could not have done the paperwork without it.

Doing the paperwork for a OEM laser product is not that hard. Much easier then for a whole projector.

Quality control testing, putting on the right OEM use sticker, and keeping a record of whom you have sold to for seven years. Thats it.
YOU write the QC procedure and specify the test gear used, not the FDA. If your lucky, a FDA REO comes by once every two years to inspect your records. I know people who have never seen a REO, and they tend NOT to come around if they hear from you on a phone.

When I did the variance with my pal, I called the local REO specialist and went proactive. I asked him what he wanted to see. He told me. We incorporated that into the vari and manufacturer's report. That is the job of the REO, to advise, I guess. I think advising is a lot easier then "enforcement".

If you decide to do the process, which is easy, call your local Regional Electro_Optical Specialist, that is what they are there for, or DC and get the dope on what you need to do. Its FREE except for your time, postage, and phone calls. Doing the "process" beats the heck out of loosing your means of support, in the 1 in 10,000 chance you get sued by a injured customer. Odds are the customer will be in the wrong, not you, but you are the one the lawyers can "hang out to dry".

Most of the time when I encounter "Laser Safety" it is the venue, corporate, or university safety staff that asks questions and demands compliance. When teching on laser shows, it is the local fire marshal that asks questions, and I have met more then one of them. Its not the government who is concerned, as much as those who rightfully fear the consequences of making a mistake.

I actually sought out my present employer's LSO, better to be proactive and see whom your dealing with, then to meet them during a inspection and get hammered for something stupid. They can easily shut me down at my present employer, at the last one, it was advisory unless there was immediate danger.



Steve