Hi. I would like to confirm laser safety requirements in an industrial machine under the U.S. FDA regulations. If a Class II laser module (purchased OEM) is installed in an industrial type machine, my understanding is that the machine manufacturer must adhere to the following requirements: 1. The machine must provide additional enclosure for the device so that the operator is not exposed to levels higher than Class I during machine operation. 2. The machine manufacturer would be obligated to test the machine to confirm that the Class I levels are indeed not exceeded and submit a report to the FDA. 3. If the additional enclosure for the device can be opened or removed by the operator, the enclosure must be safety interlocked. 4. The machine manufacturer would be required to keep records and report unit sales to the FDA on an annual basis. Is my understanding of the 4 points above correct? If so, am I missing any else? Thanks. Jim Hulbert This email message may contain confidential, proprietary and/or privileged information. It is intended only for the use of the intended recipient(s). If you have received it in error, please immediately advise the sender by reply email and then delete this message. No one other than the intended recipient may disclose, copy, distribute or use the information contained in this message.
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