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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device booth, sun tan
Regulation Description Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
Product CodeLEJ
Regulation Number 878.4635
Device Class 2


Premarket Reviews
ManufacturerDecision
ADAC
  SUBSTANTIALLY EQUIVALENT 1
LIGHT SOURCES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Electrical issue 1
Inadequate training 1
Improper or incorrect procedure or method 1
Total Device Problems 3

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 1 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 JK Products & Services, Inc II Sep-12-2014
2 JK Products & Services, Inc II Sep-07-2012

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