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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device eyelid thermal pulsation system
Regulation Description Eyelid thermal pulsation system.
Definition Therapeutic application of heat and massage to the eyelids.
Product CodeORZ
Regulation Number 886.5200
Device Class 2

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Tearscience, Inc II Oct-17-2016

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