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As the name suggests, Laser Compliance is all about laser product compliance consulting.

US LASER LAWS

All products containing lasers which are imported or sold in the United States must be certified to comply with special U.S. laser rules.  These US requirements are different and more complex than those required by the European IEC 60825-1 regulations.   Many US laser products must have additional special testing and certification that is not required in other countries including Europe. 

European laser manufacturers must only make their products meet the IEC 60825-1 rules.  Manufacturers and importers of products to the US must meet other rules and regulations.  Also, US manufacturers must report their products to the United States Food and Drug Administration (US FDA) for a type of prior approval. 

These laser product reports are typically 35 to 60 pages in length and require specialized analysis and data.  Additionally, lasers may be classified differently in the US and the EU.  Some types of laser products require special pre-approved Licenses to build and import.  Manufacturers and importers of lasers must also file additional special reports once a year.

In the US, lasers may be classified under one class for manufacture yet under another class for use. 

The division of the US FDA which is responsible for lasers is the Center for Devices and Radiological Health (CDRH).  This US government organization travels to laser manufacturing factories all over the world to inspect the lasers where they are being built. 

Call or write Laser Compliance today for more information on our services and rates.

Telephone: 801-495-9746 / Fax: 509-562-7412 / Email: info@lasercompliance.com

Telephone: 781-255-1064 / Fax: 781-255-1065 / email: info@bluehilloptical.com

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