Compliance

Laser Guardian is your support resource focused on the safe use of lasers. We have an excellent history in laser compliance testing and accession document submittals to the FDA. We can support all phases of the FDA submittal from writing the emission tests to compiling FDA form 3632 so it is ready for signature and submittal. The certification of a laser or laser system is a mandatory requirement under FDA regulation 21CFR1040 and applies to all laser systems manufactured or imported into the United States with very few exceptions. Compliance testing ensures that the laser system is safe to operate at the designated laser hazard class level. It also provides evidence that the required administrative and engineering controls are functional and meet federal requirements. Non-compliance can result in fines up to $300,000 along with product recalls. Although compliance to the international standard IEC 60825 does fulfill many of the requirements for 21CFR1040, it is not recognized as a regulation substitute by the FDA. An accession number submittal must be generated for IEC 60825 certified lasers imported from other countries.

Laser Guardian uses a wide range of laser sensors to ensure the proper device is used to test your system for emissions. We cover laser wavelengths from 200nm to 10.6um. All sensors and meters are factory calibrated and NIST traceable per FDA requirements.

We calculate the AEL (acceptable emission limit) based on mathematical formulas from the FDA. All equipment is tested under worse case conditions to this emission limit with statistical justification for variance and data sampling. This ensures that the testing methodology is to the expectation of the FDA.

We stand by all submission documents generated by Laser Guardian and will provide rapid support to our customers if any of the document content is questioned.

Although we prefer to work alongside the system builder from the early development stage, we understand that sometimes this is not possible and submittals must be rapidly generated to meet customer needs. We will be on-site with the system builder team to make this happen using our same high level of quality.

Certification is more than adding labels

Laser Guardian will develop a robust emission test protocol and detailed report to ensure your system is 21CFR1040 compliant. We can provide test support or generate the complete FDA form 3632 for accession number submittals to meet your specific needs.

Certified through functional testing

Laser Guardian has a complete line
of NIST traceable calibrated test instruments. We can perform emission tests from short UV wavelengths of 200 nm through long Infrared of 10.6 um.