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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lens, spectacle, non-custom (prescription)
Regulation Description Prescription spectacle lens.
Product CodeHQG
Regulation Number 886.5844
Device Class 1


Premarket Reviews
ManufacturerDecision
GENTEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
VISION-SCIENCES, INC.
  1

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 1 0 0 2 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Eyemart Express Ltd II Dec-16-2014
2 Luxottica Optical Manufacturing II Mar-07-2011
3 Wal Mart Stores, Inc II Jun-17-2014

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