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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device optical diagnostic device for melanoma detection
Definition Intended in the detection of melanoma and high grade lesions among atypical lesions in order to rule-out melanoma.
Product CodeOYD
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 0 0 0 1 2 0 4 2 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 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 MELA Sciences, Inc. II May-20-2015

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