COMPLIANCE

 

Regulatory Compliance: Laser Product Performance Standards

Manufacturers of lasers and products that contain lasers must submit product reports, supplemental reports and/or abbreviated reports to the Center for Devices and Radiological Health (CDRH) prior to introduction of the reported products into commerce and/or import into the US.

 

A product report is a report submitted by the manufacturer of a regulated product, i.e. lasers and  products that contain lasers, and describes the product and details how the product complies with the applicable standard. Standards include Federal Laser Product Performance Standards (FLPPS) 21CFR1040.10 and 21CFR1040.11 and/or IEC 60825-1 (International Standard) and explains the quality control program to assure compliance. When product reports are received at CDRH a unique accession number will be assigned for future reference.

 

Contact LASEResources to support the research, design and development of your laser products, automated processes and robotic cells in compliance with FLPPS and/or IEC 60825-1 and the accurate completion/submission of your laser product reports for issuance of an accession number required for sale and distribution.

 

​​ANSI Compliance: Workplace Laser Safety

Personnel who work with Class 3B or Class 4 lasers, or Class 1 lasers that contain embedded Class 3B or Class 4 lasers meet the definition of authorized personnel; Individuals approved by management to operate, maintain, service, or install laser equipment. In these work environments the employer shall appoint a Laser Safety Officer (LSO), implement a laser safety program and provide employee laser safety training.

 

Contact LASEResources to provide ANSI Z136 compliant workplace laser safety program development, employee training, qualitative laser hazard analysis and workplace safety audits. We can also contract with your company to serve as interim acting/advising LSO to develop your ANSI compliant workplace laser safety program, establish/implement appropriate controls measures and provide safety training for your employees.

 

LASEResources also provides R&D, clinical application, technical, regulatory, and monitoring support for preclinical research and FDA-approved Phase II & Phase III multi-center clinical trials and approved indications of medical lasers, laser-based treatment and instrumentation.

 

Note: Laser compliance projects are supported by board certified laser safety officers (CLSO)