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Laser Compliance > Why You Must Comply
Laser Laws & Regulations: Why you must comply with FDA Regulations
If you manufacture or import products that contain lasers, you need to comply with the CDRH laser regulations in the U.S. and laser laws and regulations of the countries where you have business activities.
At Laser Compliance®, we provide experienced, professional Laser Compliance® consulting services for laser product manufacturers to meet laser laws & laser regulations. We have helped hundreds of companies worldwide, from Norway to New Zealand, South Africa to China, Korea to Israel comply with laser laws.
These laser regulations are especially important for manufacturers and importers in the United States and Europe. The regulations cover, in detail, areas such as FDA laser classification, reporting, user information and record keeping. A typical government inspection can uncover a dozen violations. Serious violations can -- and have -- led to products being recalled, repaired, replaced and even refunded. Fines of up to $330,000 can be imposed if you do not follow proper laser regulations.
Here's a quick overview of what governments require of you ... and how we can help.
Governments impose detailed laser safety requirements in the U.S. and other countries:
 Laser certification & classification
Initial reports
Annual reports
Engineering design features
Product certification
Safety labels
User manuals
Record keeping
Import and export requirements
Why comply with laser regulations? If you don't comply with the laser laws and regulations, the penalties can be severe:
No importation permitted
Customs impound and/or product destruction
No sales permitted
Recall and repair every unit
Recall and replace every unit
Refund the money for every buyer
Fines of up to $330,000 for each occurrence
At Laser Compliance®, we help you comply with all laser laws and requirements, so you have regulatory
peace-of-mind.
Product design assistance and advice
Complete laser product safety regulation compliance
Import and export assistance
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