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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ophthalmoscope, ac-powered
Regulation Description Ophthalmoscope.
Product CodeHLI
Regulation Number 886.1570
Device Class 2


Premarket Reviews
ManufacturerDecision
ALCON
  SUBSTANTIALLY EQUIVALENT 1
APPASAMY ASSOCIATES
  SUBSTANTIALLY EQUIVALENT 1
BIOPTIGEN, INC.
  SUBSTANTIALLY EQUIVALENT 3
CANON
  SUBSTANTIALLY EQUIVALENT 2
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 6
HEIDELBERG ENGINEERING
  SUBSTANTIALLY EQUIVALENT 5
MIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
OPTOS PLC
  SUBSTANTIALLY EQUIVALENT 2
OPTOVUE, INC.
  SUBSTANTIALLY EQUIVALENT 7
TALIA TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 5
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 5

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

Recalls
Manufacturer Recall Class Date Posted
1 Carl Zeiss Meditec Inc II Sep-03-2009
2 Keeler Instruments Inc II May-22-2008
3 Optovue, Inc. III May-31-2013

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