Reporting Guides and Forms

Forms

• CeSub Electronic Submissions Program
  This is the link to the CDRH website that contains the information on the electronic submittion program.

• Reporting Guide - Radiation Safety Product Report for Laser Products or [WORD]
  The Reporting Guide contains the basic report form and instructions. When the instructions are removed there are 25 pages that need to be filled out. Normally completed reports are approximalty 35 to 150 pages in length.

• Reporting Guide - Radiation Safety Product Report for Laser Light Shows/Displays
  This is the Reporting Guide used for manufacturers of Laser Light Shows and Displays. If you also manufacturer the show equipment you may need to supmit a Laser Product Report. If your show uses Class 3B or 4 laser products you may also need to submit a Variance Application.
  

• Variance Application for Laser Products used for Light Shows and Displays or [WORD]
  Manufacturers of laser products, light shows, or laser displays may need to submit a Variance Application.

• Reporting Guide - Annual Reports or [WORD]
  Unless an exemption or variance is obtained manufacturers are required to submit and Annual Report. This guide contains the instructions and report form used to prepare this document.

• Import Form 2877
  Importers of laser products will need to prepare and submit a 2877 form to US Customs and/or the local FDA office.