抄録
Pharmaceuticals and Medical Devices Agency (PMDA), which reviews high-risk medical devices,
summarizes new guidelines about medical lasers through discussions with academia and industry. The
guidelines offer basic concepts about the evaluations of medical lasers that are not limited to laser
scalpels. PMDA believes that this activity promotes novel medical laser development. This article
introduces the contents of recent PMDA activity and new basic thoughts about medical lasers.
