LSC will review with the manufacturer the design and application of the laser product, which usually requires an on-site visit in order to examine the product in detail. The manufacturer will be responsible for providing in a timely fashion all documents, drawings, photos, applicable component specifications and other information needed in order to complete the report. The time required for and cost of preparing the Laser Product Report depends on the design and application of the laser product. LSC will deliver the report ready for the manufacturer to sign and submit to the CDRH. Upon submission of the Laser Product Report the product may be delivered, installed, and operated. Approximately six weeks after the report is received by the CDRH the manufacturer will receive a letter acknowledging its receipt. LSC will assist the manufacturer in the event that the CDRH has any questions or concerns regarding the report, and this will be at no additional cost provided that the questions or concerns do not involve information not made available LSC prior to submission of the report.
LSC is also equipped to assist manufacturers in meeting safety requirements for laser products sold outside the U.S., where the applicable standard is IEC 60825-1 Ed. 1.2 Safety of laser products, Part 1: Equipment classification, requirements and user's guide.