information

Overview

This system has been tested by a CARAT Certified Laboratory of TÜV SÜD America operating in conformance with ISO/IEC/EN 17025, General Requirements for the Competence of Testing and Calibration Laboratories. It has been certified as a class 1 eye safe device that conforms to all FDA/CDRH

Finding of fact by the laboratory and as filed with the FDA/CDRH

Summary

The product covered by this investigation is an individual handheld laser, capable of producing pulsed emissions. The measurements performed under this investigation were performed on the free space emissions that the “as received” equipment under test, was configured to produce; as provided. Multiple measurements were performed of this specific configuration to attempt to obtain worse case results of this specific emission. based upon the assumptions, testing, equipment under test configuration, measurement conditions, and the calculations performed under this investigation, the product was determined to be a Class I laser product employing Class I laser radiation emissions in accordance with US FDA CDRH 21CFR Subchapter J, Parts 1040.10 and 1040.11.