USA Laser Upgrades.

We take your imported, non-compliant and/or custom Laser systems and get them legal for use in the USA.

 

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Laser Product Certification

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Percentage of Imported Laser Systems that are Non-Compliant to U.S. Standards

Average Time for Laserupgrade.com to PROPERLY Report and Certify a Laser System (In Days)

Approximate Time Required (In Months) Needed For Someone Unfamiliar With The FDA/CDRH Rules and Regulations To Get A Product Certified and Compliant

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1 + 2 =

LASER PRODUCT CERTIFICATION AND OPERATORS VARIANCE.

Let Us Navigate Through All of The FDA/CDRH Paperwork and Regulatory Requirements!

Simply put, Laserupgrade.com takes your non-compliant, imported and/or custom Laser system and performs the necessary modifications, certifications and reporting to get the Laser system legal, certified and able to be used in public. These Laser systems include, but are NOT limited to:

– Laser Light Show Systems
– Component Laser Systems to be incorporated into end products
– Medical Laser Systems
– Military Laser Systems
– Single Laser Component
– Multiple Laser Components
– Complete Laser Product Line
– Industrial Laser Systems
– Imported, Non-Compliant Laser Systems

Why do you need our services?

Laser systems in the USA, from 4.95mW (milli-watts) and greater, are restricted for use under very stringent regulatory requirements. This includes very specific safety systems, quality control programs, proper labeling, proper reporting and many other factors. These Federal regulations govern ALL Laser systems. Whether it is a Laser pointer, a Laser light show system, an industrial CO2 Laser cutter or ANY other type of Laser system. If it is a device that emits a visible and/or non-visible Laser beam, it is a “Laser system.” These systems, as mentioned earlier, are governed and regulated under Code of Federal Regulations Part 21.

Unfortunately, with the ease of purchasing products on the Internet, many, MANY of these Laser systems are purchased and imported into the United States illegally. Not only are most of these Lasers illegal, they are usually operationally unsafe!

Laser Systems in the USA need very specific reporting, licensing (known as a “variance”), certifications and operators licenses. Laser systems that are imported from foreign countries and even some domestic sales do not adhere to these guidelines. These “Rogue” Laser systems pose serious legal risks, safety risks and even possible criminal liability to you.

Laserupgrade.com does all of the work for you. We take your system and make it compliant. We work very closely with the CDRH (CDRH is a branch of the FDA which is responsible for Laser products) and make sure that when you receive your system back, it is 100% compliant with a product certification and a Laser operators variance.

What is Needed?

Do you need to do a product report? Do you need to file a variance? Doe you need to fill out an OEM importation form? Does your Laser system require a delay? Does your Laser system need to have “DANGER” labels, or does it just need to have “WARNING” Labels? (YES- there is a difference!)

These questions and their answers is enough to make your head spin! Laserupgrade.com knows the laws, we know the regulations and we work with the CDRH to maintain impeccable Laser compliance.

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Laser Light Show Systems

Imported Laser Light Show Systems, custom made Laser Light Show Projectors and even some Laser systems purchased in the USA do not conform to the standards set forth by the FDA/CDRH under 21 CFR Part 1040. Laser systems purchased on Ebay, Online stores, from China (with a few exceptions) and MANY other places are not “Legal” for use in the USA. This means that there are hundreds, if not thousands of potentially dangerous Laser systems inside your local bar to the biggest of nightclubs and concert venues. Do you own one? We aren’t here to judge or report you. We are here to HELP you become compliant!

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Laboratory Laser Modules

Remember, ALL Laser systems require that they adhere to and comply with the law. This includes Laser systems used in a laboratory or scientific, research setting. These Lasers will need to be certified, properly labeled, properly delayed lasing, key operated…etc.

Laserupgrade.com will take your system and properly modify it and report it so that it fully complies with the 21 CFR part 1040 Standard.

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OEM Laser Modules

Many people think that, “Well, its just an OEM Laser module, it doesn’t need to conform to any standards.” WRONG! While, yes- the module by itself can be classified as an OEM module, but how does it get shipped? Can it be imported? Can the Laser’s power supply be shipped with the Laser? Does it need any specific importation paperwork? Avoid the headaches and confusion! Let us do it for you!

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Industrial, Medical, Military Lasers

Any device that emits a “Laser beam” is a Laser device. It doesn’t matter if it is for Laser light shows, medical advancements, military applications or industrial Laser applications. A Laser, is a Laser. Therefore, it is a necessity to be compliant to the law. Laserupgrade.com will help you to get your product to market, legally! The hassles and confusion trying to navigate through all of the required paperwork and guidelines is cumbersome at best. We do it 10 times a day! Let us take the confusion and stress away from you.

Service Packages

These are just approximations. Please understand pricing can change drastically depending on complexity of the situation.

LASERUPGRADE.COM
+1 (347)-606-1076
LASERUPGRADE@LASERUPGRADE.COM
BROOKLYN, NEW YORK. USA