Certification

A laser manufacturer is any person or organization in the business of making, assembling, or importing laser products. Under the Radiation Control for Health and Safety Act of 1968, laser manufacturers are required to provide notification and self-certification of any laser product prior to sale within the United States. This is accomplished by filing a Laser Product Report with the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH). The requirements for this Laser Product Report are specified by the Federal Laser Product Performance Standard (21 CFR Parts 1040.10 and 1040.11).

Laser Safety Consulting LLC.. can assist manufacturers in ensuring that a laser product meets all the requirements for classification and certification specified by this standard. This includes each of the following parts of the Laser Product Report:


  1. Manufacturer and report identification
  2. Product and model identification
  3. Compliance with the labeling requirements
  4. Compliance with the informational requirements
  5. Description of the product
  6. Levels of accessible laser radiation and classification of the laser product
  7. Compliance with the performance requirements
  8. Quality control tests and testing procedures
  9. Life and endurance testing
  10. Instrumentation and calibration

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.



Laser Safety Consulting, LLC.
621 Lochtyn Ridge
Wales, Wisconsin  53183
Phone:  (262) 370-2454   Fax:  (866) 296-9193
 Email: 
LSC@wi.rr.com





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