The Review of Laser Engineering
Online ISSN : 1349-6603
Print ISSN : 0387-0200
ISSN-L : 0387-0200
Laser Review
Approval Review of Medical Laser Devices
Yutaku KANETA, Yutaka TOMIOKA, Takehiro ICHIKAWA, Hiromi KUROKAWA, Yuka SUZUKI
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Keywords: Pharmaceuticals and medical devices agency (PMDA), Medical devices review, Medical laser, Laser scalpel
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2016 Volume 44 Issue 3 Pages 179-

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Abstract
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.
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© 2016 by The Laser Society of Japan
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