Inactive Total Small Business Set-Aside (FAR 19.5)

FDA/CDRH reviews and regulates safety and efficacy of medical diagnostics and therapeutics devices and marketed products involving non-ionizing coherent (laser) and noncoherent broadband optical radia... FDA/CDRH reviews and regulates safety and efficacy of medical diagnostics and therapeutics devices and marketed products involving non-ionizing coherent (laser) and noncoherent broadband optical radiation sources. However, in many cases of new technologies and products, we face major challenges of lacking standard test methods, protocols and tools for safety and efficacy evaluation of emerging laser radiation products. Development of novel femtosecond laser (FSL) technologies and products is an emerging field with significant public health impact on various biomedical areas including ophthalmology, dentistry, neurosurgery, cancer diagnostics and therapeutics, and nanotechnology. A critical test equipment for multifunctional safety evaluation of FSL radiation characteristics and accomplishing the research goals of the LORS project is the requested High Power CW 532 nm DPSS Laser System that will be used as a powerful green (532-nm) laser source for pumping of an existing tunable FSL system. It will provide a FSL source in a broadly tunable near-infrared spectral range including the specific laser wavelengths required for safety evaluation in two-photon imaging and therapeutic applications.