Hi all -
Below I have copied the text of a release that was just blasted out to all of our dealers, reps and customers. Two folks have been caught by FDA already and neither knew they were doing anything wrong. Just FYI - and a big thanks to Marc for being the first to tell us about these folks!
Over the last several months X-Laser, an FDA varianced manufacturer of laser projection systems, has been monitoring the growth of a Chinese company calling itself “X-Laser Hong Kong” (or X-Laser HK, or just X-Laser), which has been aggressively marketing non-compliant laser systems labeled as X-Laser product. For clarity, we will refer to ourselves as X-Laser USA and the infringing company as X-Laser HK from here forward.
X-Laser USA is aware of several instances where US customers have purchased X-Laser HK product thinking the products were genuine X-Laser USA and in at least two cases even attempted to file a variance application with the FDA. We will say at the outset that X-Laser USA and X-Laser HK do not have, and have never had, a business relationship of any kind, period. X-Laser HK is a shell company for a larger Chinese laser manufacturer which is illegally using X-Laser USA’s registered trademarks to confuse the marketplace and trick consumers into purchasing lasers which are not legal for sale in the United States. They even now state that they can produce an “FDA Certificate” which is, in reality, nothing more than a letter from the FDA which even specifically states: “This acknowledgement does not constitute an approval...” They also use an FDA accession number as proof of compliance with FDA regulations but an accession number is just a document tracking number with no relevance to legal compliance.
Further, X-Laser HK’s products have been caught and inspected by U.S. Customs and Border Protection and were found to contain numerous deficiencies including safety defects. http://www.accessdata.fda.gov/script...ineId=1&SfxId=
Dealers, users and industry professionals contacted by this firm are strongly advised to delete any such solicitations and/or refer them to the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) (or email us at report@x-laser.com) for further action. Due to the security measures built into X-Laser USA’s variance program, it is very easy for the FDA to distinguish between real X-Laser USA product and counterfeit product from overseas. FDA will not accept or approve variance applications for ANY product which is not properly product reported and produced by a varianced laser projector manufacturer including X-Laser HK as well as myriad other laser light show manufacturers.
X-Laser does not ship product into the United States from overseas. All radiation emitting product compliance, quality assurance and testing must be done locally in order to comply with Chapter 21 of the Code of Federal Regulations Section 1002. If you receive an offer of sale from outside of the United States we strongly encourage you to contact us at sales@x-laser.com to verify the identity of the seller. Purchasing illegal laser products will expose you to Federal fines ranging up to $355,000.00 per unit (21CFR17.2).
If you discover what you believe to be counterfeit X-Laser product being sold anywhere in North America, please contact us at the e-mail address above or at http://www.x-laser.com/contactus.fwx for immediate investigation.
Finally, we would like to note that while copyright infringement in general is sometimes treated very casually, producing counterfeit radiation products creates much more serious and very real safety concerns for both the purchaser and those who may view the show. Beyond stealing from a hardworking USA company that works their butts off creating the world’s most affordable high powered laser products, those who would make such lasers even cheaper cannot possibly be using the quality parts, as we do, which allow us to certify each unit we make to meet the most demanding standards of safety and reliability in the world. Make no mistake, besides being illegal to buy or use, illegal laser products contain numerous and often invisible hazards which can cause serious health problems including loss of eyesight and skin burns.
We appreciate the thousands of users, dealers and friends who trust X-Laser USA’s products to produce fantastic laser shows for their clients and wish X-Laser HK a speedy departure into the dustbin of history.