D.L.S. provides regulatory compliance services for lasers and products or devices that incorporate lasers. The D.L.S. Laser Compliance Program offers consulting and testing services for U.S. and European Union laser safety compliance to manufacturers of such products and devices. Let D.L.S. 's expertise provide the fastest, most economical route to regulatory compliance.

Equipment incorporating laser devices and embedded lasers must always meet regulations applicable for the region into which it is put into service. Since the Publication of Laser Notice No. 50 by the Center for Devices and Radiological Health (CDRH, an arm of the FDA) in July 2001, laser safety for equipment installed in the U.S. can now be evaluated according to IEC 60825-1 (including Amendment 2). The availability of this IEC alternative to the Code of Federal Regulation 21 CFR 1040.10 and 1040.11 means that laser safety can be evaluated under a single set of requirements covering not just the U.S. and the European Union, but a host of other countries that have adopted the IEC standard. This streamlined approach saves both time and money.

In addition to general laser applications (primarily ITE, industrial, audio/video and household), CDRH Laser Notice No. 50 also provides an IEC alternative for lasers used in certain medical applications, specifically for Diagnostic and Therapeutic Laser Equipment, by allowing the use of IEC 60601-2-22.

Contact D.L.S. today to discuss your laser application. Our experts will guide you through the regulatory aspects of your equipment's laser application and allow you to meet global compliance requirements, including FDA and IEC specifications.

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