Food & Drug Administration (FDA) Laser Product Compliance

The Food and Drug Administration (FDA) requires that all lasers manufactured in the United States or imported into the country must comply with 21 CFR Sub Chapter J 1010 and 1040.10 Laser Product Performance Standards. It is the responsibility of the laser manufacturer to self-certify that their laser or laser system complies with the requirements of the FDA. Part of this self-certification requires the submission of a product report of the laser system. This can be a tedious problem for the laser manufacturer or system integrator, and they may find themselves at a loss as to how to proceed. GCA Laser Safety can assist in this process.

GCA Laser Safety can help with:

• Classification of the laser system
• Determining accessible emission limits
• Providing performance requirements
• Labeling requirements
• Preparation of the product report for client submission
• Assisting clients with the submission of the product report to the FDA

Contact GCA Laser Safety for more information on how they can assist.

Email gus@gcalasersafety.com or call (407) 900-4657