I’m going to ask you all to bear with me here. I tried to find a way to divide this into a couple of posts but, well, it’s so intertwined and problematic that I couldn’t figure out a way to do it. This is gonna be a long one, but I hope educational.

TL;DR version: Don’t waste your money on Cubiio. You’re never going to see it. If you somehow get it, you’ll be breaking the law by using it.

Let’s start here by discussing my day job. While you might think that the production of ultracoffee would afford me zillions, health benefits and a life of luxury most people couldn’t even dream of, that isn’t the case. I am a radiation safety professional, AKA health physicist, who is tasked with wrangling the radiation producing machines (x-ray units, electron microscopes, particle accelerators, etc.), maintaining all the radiation detection instrumentation (Geiger counters and such) and, unofficially, The Weird Shit (when you open up a closet that’s been nailed shut for four decades for some reason and there’s an unmarked box that sets off the Geiger counter, you call Phil). But due to long familiarity with the field and experience building high powered industrial/scientific lasers, I am also the deputy laser safety officer for the campus. The day before I flew off to South Pole Station, I sat for the Certified Laser Safety Officer exam and was issued certificate G006. Certificates G001-005 went to the members of the certification board. So, yeah, I’m not just RADIATION DUDE, as is often yelled at me from the facilities & trades trucks driving by, but I am also LASER DUDE.

 

 

 

 

 

 

 

 

 

 

 

 

What this means is that everyone’s very prone to seeing things online and thinking “This $RADIATION_OR_LASER_ PRODUCT looks fascinating-bad. I bet Phil would lose his goddamn mind in an entertaining way if I sent it to him.” This has gotten much, much worse in the age of crowdfunding. I have a few dozen bookmarked websites and campaigns that are ALWAYS OPEN at work to look at, just in case I need to replenish the rage that keeps me alive. My Lovely Assistant, because she was clearly worried about my blood pressure getting too low, sent me this gem on Wednesday, which set me off on a goddamn quest. I am going to use this project as an object lesson for several different things that bother me. I’m not even going to comment on how good or bad this thing is at engraving/cutting things because it’ll very likely never legally see the light of day in America or Europe. Let’s start with the operating characteristics of this laser, as best as I have been able to pull together for this system from the project page:

• Operating Wavelength: 450nm (blue laser, insert Homestar Runner jokes here)
• Operating Power: 500mW open air, 800mW in enclosure
• Operating Mode: unclear, appears to be a continuous wave rather than pulsed
• Laser Type: diode based solid state (likely an OSRAM 1.6W blue diode, with the power dialed down so as to not destroy their steering optics)
• Emissions Indicator: Not really, but the on button lights up when pressed so that’s cool.
• Aperture Labeling: No
• Shutter: No
• Interlock: None apparent. Really, other than password control for the app (pfft), doesn’t look like there’s interlocks of any kind, much less fail safe ones.
• Control Software Integrity: unclear, but based on my experience with other “Agile Development” projects, pfffftHAHAHAHAHAHAHA.
• CDRH Labeling: No, but then that would assume the FDA’s Center for Device and Radiologic Health had already approved it. We’ll get back to that later.
• UL/CE Marked: unclear, but looks like no. If you make it through Underwriters’ Lab testing, you toot that horn.

Before delving too deep into the problems of this product, lets take a moment to review the laser classifications and how they relate to the hazards they present. For laser safety classification, we have a slightly complicated classification system that runs like this:

• Class 1: no accessible laser hazard during normal operation. There may be powerful lasers embedded in there but you can’t get at them. (e.g. laser printer)
• Class 2/2M: not a viewing hazard under normal conditions, less than 1mW average power, usually with highly divergent or rapidly scanning beams such that the blink reflex saves you. Just…don’t stop the scanning head or add focusing optics, okay? (e.g. bluray player, supermarket checkout)
• Class 3R: less than 5mW average power, visible wavelengths only, safe under normal normal viewing conditions without magnification (e.g. your typical red laser pointer)
• Class 3B: 5mw-500mW average power, direct/reflected beam presents both an eye and fire hazard, diffuse reflections of the beam are theoretically safe but the higher the power the less okay it gets. (e.g. your bullshit illegally imported green laser pointer you bought online, most laboratory lasers for analysis of delicate molecules)
• Class 4: >500mW average power, direct beam and diffuse reflections presents an eye, skin, and fire hazard. We’re talking blinding, burns, and fire alarms if used improperly. (e.g. any cutting laser, most laser light show systems, the Death Star, your EXTREMELY BULLSHIT “laser pointer” you bought online)

NOTE: If you have a Wicked Lasers product anywhere that I have authority and you don’t have a very convincing research purpose for having it, I will confiscate & destroy it promptly. They aren’t worth the trouble, their QA is terrible, and are nothing better than Geneva Convention blinding weapons. Yes, I know they look like lightsabers from Star Wars; they did this on purpose which is why Lucasfilms sued them. REGARDLESS, THEY ARE STILL ILLEGAL TO IMPORT AND USE IN AMERICA.

So this system would qualify, at a minimum, as a Class 3B visible wavelength laser which means it presents a retinal injury hazard, probably even with its scattered beams. Assuming the optional enclosure is worth a crap with interlocks that actually prevent the laser from turning on until it’s closed, it could then be a Class 1 with an embedded Class 4 system. There is a reason why all the laser cutters/engravers other than Cubiio are inside of enclosures, because you get the benefit of not needing protective eyewear or needing to restrict access to the entire work area to use it; the laser hazard is completely contained within the enclosure. Of course, the laser hazard isn’t the only problem because whatever you’re engraving with this laser is going to turn into a fine nanoscale particulates. Do that to a pancake and you make pancake smells; do that to a phenolic resin integrated circuit board and you get much more fascinating airborne particulates. The acronym for these are LGAC, Laser Generated Airborne Contaminants, which can go straight through most HEPA filters because they’re so small. The zeolite & activated charcoal indicated in their enclosure design are great for airborne organic volatile chemicals…for a few weeks at best the activated charcoal is useless after from exposure to air and they’re more or less useless against particulates this small. But at that point we’re talking industrial chemical safety and airborne release considerations, not laser safety.

Let’s be clear, my main objection to this entire project is the “open air use in public” aspect. Pretty much everything else can be fixed except, if you watch their video, this is their goddamn selling point. In the open air use, you are just asking to scatter that beam off of something and lase a bystander in your vicinity. Do that outside, lase toward the sky and hit a plane? You just made friends with the FAA and a terrorism charge which carries a $500k fine and federal prison time. When you do public use of a Class 3B or 4 laser you’re required to submit to the FDA-CDRH, in some detail, exactly how you’re going to set up and prevent people from getting burned by your operation. Assuming you’re approved, you are granted what is called a variance (as in, what you’re doing varies from the enclosed and safe operations CDRH really approves of) to use your laser as described. Laser light show operators may get general variances that let them do their operations in a variety of different venues, but still answering the same question “How are you going to keep the general public from hurting themselves with these?” Please note that all this work is on you, the laser operator, to do go through the CDRH variance process, not the laser manufacturer. 

(If you’re doing laser fun that involves shooting up into the sky, you have to give times, directions and power to the FAA so they can divert air traffic as needed. They will never say “OKAY, SUPER, SHOOT THAT BAD DOG ON UP HERE!” Instead, the FAA sends letters of non-objection to let you do your laser light show, which is as positive as they’re ever gonna get. I don’t know about you, but this might explain why you don’t see lasers at concerts so much anymore.)

The missing interlocks, labeling and indicators I can chalk up to a bad case of modernist Apple Design Disease, where if your product doesn’t look like it might be made by Apple then you clearly have too many “things” on it. You fix that by realizing you aren’t making an iPhone; this is a high powered laser…which you can control with an iPhone. Actually, that’s a problem too. Generally, we in the safety and industrial design gig aren’t big fans of hazardous equipment that you can operate remotely. We like it when you have to be there with direct line-of-sight when you’re operating equipment with high powered lasers, swinging robot arms, etc. to prevent you from turning on the band saw remotely from the toilet and causing a surprise amputation for a coworker. OSHA takes a very dim view of this. Contrast this with the bluetooth enabled, wireless, Internet-of-Shit, phone as magic wand future our consumer product producers are taking us toward. I’ve gone to Consumer Electronics Show (well, bartended at a safe distance) for the last three years and seen what they’d like to give us. When you start trying to turn industrial tools, like laser cutting units, into consumer products with consumer expectations of what a modern wireless smartProduct should be like, you’re going to have problems. OtherMachine did well at this; this project not so much.

Makers vs. Manufacturers

I have some misgivings about maker culture despite, well, being one. I’ve lost count of the number of times someone brings me a neat concept where I rain on their parade by pointing out that their new innovative features and convenient operation are really just removing all the safety controls that a properly designed consumer product should have. The key words here are “consumer product”. If you want to tear apart a laser printer to get at the Class 4 laser within to build a novelty laser that will burn funny pictures on your steak, go for it. As a private citizen in the United States, it is your right to tear whatever you own apart and tinker as part of your 1st Amendment freedom of expression. But much like Oliver Wendell Holmes’ saying “The right to swing my arms in any direction ends where your nose begins”, your right to tinker similarly ends when your laser beam hits someone else or you try to sell your creation. The don’t hurt other people bit is relatively straightforward, so lets go to the part that isn’t: selling laser products.

You may argue that one of the problems is that technology has advanced and that these regulations are antiquated, that they no longer apply to the world as it now is. Since laser diodes first hit the market, laser systems have gotten smaller, cheaper, and more powerful every year. Once upon a time, not very long ago, you could rely on the fact that a 40W laser with good beam quality would be a serious capital investment in the five to six figure range, you were gonna need some serious utilities to plug it into, a chilled water system to keep it all from overheating, which means you’re talking a laser bench and maybe a dedicated room. Now you can buy all that as a single diode module you can hold in your hand for a couple hundred bucks and can run it off of wall power or even just batteries. If you’re creative and not as picky about QA,  you can get it at higher powers, any color you like, for cheaper than that. For a lower power but still potentially blinding laser, like a 1.6W blue laser diode module for example, you can find them as small as a pencil eraser for $12. You can buy them in bulk with a discount if needed.

Makers, when you slap a laser on your project, congratulations, you just became a laser manufacturer. Now if you’ve made this with the expectation that it would be attached to something more complete, you’re a laser Original Equipment Manufacturer (OEM) instead. GOOD NEWS: the CDRH rules don’t apply to you. For every maker and researcher that has gone apeshit at me for saying the laser diodes are dangerous as hell and that they should be allowed to buy anything because lasers don’t blind people, people do [VIGOROUSLY HUMPS LARGE COLLECTION OF AR15s], well, you win this one. You are allowed to buy and build absolutely anything you want, your research will not be stifled. In the confines of your own home or laboratory, you can do whatever you like with your lasers.

But heaven help you if injure somebody with your uncertified laser.

(This is not me in this video, but I sure have been sent it a lot times. This guy is terrifying.)

OEM products, again like a 1.6W blue laser diode module for example, aren’t supposed to be selling to the consumer market because they aren’t selling finished products. They’re selling parts. What stops you from buying these parts? Nothing, for the internet provides. Is this a problem? Depends, how much FREEDOM!!! you like in your life? The reality for this kind of shit is that it’s always been the Wild West, heading toward Mad Max these days, in terms of regulation. The only thing that used to be a restraint was cost and a limited number of manufacturers that gave the CDRH a chance to keep pace. My laser experiences have made me very aggressive with x-ray devices on the grounds of “OH, I KNOW WHERE THIS LEADS. NO! [shakes squirt bottle]” but no x-ray diodes have appeared yet, but plenty of juuuuust this side of OEM equipment crap has.

I would argue that goal of the regulations, NOT BLINDING EVERYONE AND SETTING THE WORLD AFLAME WITH DEATH RAYS, still stands (this isn’t the official mission statement of the CDRH, but I will suggest it at the next laser safety conference in 2018). You don’t throw up your hands in frustration, close all the agencies, and put your regulatory money into new Subdivisions, rather than mere Houses, For The Blind instead. Fundamentally, all of these regulations and standards exist because, at some point, we hurt someone. We will never get accidents to zero because humans continue to exist and we are nothing if not creative in how we injure and kill ourselves (SEE ALSO: all the Darwin Awards). This doesn’t mean we’re incapable of learning and trying to make it a little bit harder to hurt yourself by accident next time. But the ability to control what makes it to market has gotten much harder as time has marched on.

The Responsible Agency: FDA-CDRH

Unlike the control of radioactive materials, which have a small mountain of regulation regarding their manufacture, transport, possession, use, and disposal to prevent things from going wrong every step of the way, lasers have comparatively little control. You have one agency, the CDRH, who approves the introduction of a finished consumer laser product into commerce in the United States (NOTE: this is very specific wording) and then you have whatever your local flavor of OSHA is to tear you a new one when you blind someone. The regulations and agencies with a finger in the pie regarding lasers may be safely described as “reactive” rather than “preventive”.  In this case, commerce has a very particular definition which may be interpreted as “giving a laser you built to someone else or using it somewhere other than where it was originally built”. This may seem like an odd distinction, but it covers the fact that sometimes we don’t demand money in exchange for a laser and that the hazards of your laser may not be quite the same in one place as another. The reason why this matters is that if you are the person who originally built the laser, you have intimate hands on knowledge of the system you built and, as the creator, you theoretically know what and where the hazards you introduced to the world are and can protect yourself.

If you are going to let anyone else use this laser you have, from a regulatory point of view, you put this laser into commerce and now must comply with all the device performance standards from the CDRH. The very first performance standard requirement in the CDRH Laser Compliance Guide is:

The protective housing must prevent human access to laser radiation in excess of the limits of Class 1 (and collateral radiation in excess of the collateral radiation limits) at all places and times where and when such human access is not necessary in order for the product to accomplish its intended function.

Cubiio seems to fail right off the bat. Human access is, generally, not necessary for a cutter/engraver to perform it’s function. If you were able to convince CDRH that this product must operate without an enclosure, the regulations do allow for variances and exemptions for products from part or all of the Laser Compliance Guide, but it requires the director’s sign off. Good luck with that.

When you submit your product for approval for release into commerce, the CDRH accepts your packet and starts checking it out. In the best case scenario, where you have all your ducks in a row and have built a laser system which actually meets the product performance standards, the time from submission to granting of an accession number is in the year or so range. If there’s questions about your product, that clock can run much longer. After all, once you’re on the market, what happens with your laser is almost completely out of the CDRH’s hands so they want to make sure what they approve is solid. I say almost, because you are required to keep a log of recalls and retrofits you do of your approved product and you are supposed to notify them when an injury happens involving your CDRH approved laser. Hurt enough people and they will yank your accession number, which means you can’t legally sell that product anymore.

You are also required to put all kinds of helpful labels on your laser product, but must importantly the two that say where the laser beam is coming out of (the aperture label) and the hazard class of the laser beam being emitted. Yes, even your laser pointer has this sticker, and it probably says “CAUTION” and “Class 3R or Class IIIa” on it. Even the illegal shit from Wicked Lasers has these labels, since they’re at least pretending at legality. Because of Apple Design Disease, Cubiio lacks those.

Generally, you need to send your product for certification through Underwriters’ Lab too. This doesn’t even touch the getting a CE mark or getting through IEC certification to sell in Europe. CDRH approval is not transferable to other countries, but it’s a good sign you’re gonna make it through their process too…once you do it.

Cubiio claims to be “undergoing the certification process” for both the CDRH and IEC60825-1. Folks, if you didn’t already have this certification in hand when you started this Kickstarter, there is no way in hell this is shipping in November. Also according to their project page, they already have them built. This is a shame, because they cannot legally ship to America or Europe yet, and if any changes are demanded (and I can think of a few) they’ll have to rework them, which also means there is no way in hell this is shipping in November.

WHAT THE FUCK SHOULD WE DO ABOUT THIS?!?

I got nothing. Give me unlimited power and funding and we’ll see what I can do. (really, don’t do that, no one would like living under my Most Perfect Imperium)

The CDRH, like most regulatory agencies, is understaffed and underfunded but doing their damnedest to cover everything that comes their way. The United States Postal Service Inspectorate are the real forefront of customs enforcement for America with the wave of WTF sloshing around in our postal system, but they’ve got more or less the same problem. It’s easy to recognize illicit alcohol, firearms, and explosives traveling through the postal system yet hard to stop them compared with the sheer volume. By comparison, a small laser like this just looks like more odd electronics among a sea of such things coming from Amazon. Now add the the fact there is also UPS, Fedex, OnTrac, Amazon’s whatever, DHL…you have to depend on them to successfully interdict shit as well.

The proliferation of laser LEDs powerful enough to do retinal injury available in quantities and at prices such that you can buy them by the pound, means we’ve got a future with steady employment for ophthalmologists. The international marketplace which Amazon, Alibaba, and eBay bring to your door means that even if a product wasn’t certified in the United States, you can still buy one from overseas (China usually) and take a gamble with the postal service.

The 1st Amendment issues of freedom of expression mean that you have the right to build whatever you want with these increasingly powerful, small, and cheap lasers. Eventually, they get powerful enough we need to start considering the 2nd Amendment issues with these things and we all know how well that’s gone with conventional firearms.

But most importantly, don’t waste your money on this Kickstarter.