Greg Spooner, PhD

Greg Spooner, PhD is a physicist and laser engineer with over 30 years of experience developing medical lasers, medical devices, and photonics- and optics-based instrumentation. He has held director-level positions in R&D departments at early-stage medical laser companies and led several successful new product introductions for dermatologic and ophthalmic surgical laser products. Dr. Spooner has contributed to many successful regulatory submissions for Class II and Class III ophthalmic laser devices, including IDEs, INDs, 510(k)s, de novos and PMAs. He advises on technical issues, carries out scientific analyses, manages and executes preclinical test projects (including tissue, animal and benchtop-tests), performs technical writing services such as creating narratives for regulatory submissions or publishing pre-clinical results in scientific journals, generates laser and optical radiation safety analyses (including reports demonstrating device compliance with ANSI Z80.36 and ISO 15004-2 standards), assists in the review and preparation of software documentation for regulatory submissions, communicates with FDA, and participates in FDA meetings in support of regulatory submissions for photonics- and laser-based medical devices.