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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device high-power laser light show projector
Definition Product, laser, demo, projector, laser light show/display, class iiib/iv/3b/4; Laser projection system that incorporates a laser having a maximum radiation output power greater than 5mw.
Product CodeREA
Device Class Not Classified

MDR Year MDR Reports MDR Events
2018 2 2
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Radiation Exposure, Unintended 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Gk Photonics Inc II Aug-07-2019
2 United Nuclear Scientific Supplies, LLC II Dec-08-2017
3 X-Laser Llc II Sep-13-2017
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