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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tomography, optical coherence
Regulation Description Ophthalmoscope.
Definition Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.
Product CodeOBO
Regulation Number 886.1570
Device Class 2


Premarket Reviews
ManufacturerDecision
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 7
HEIDELBERG ENGINEERING
  SUBSTANTIALLY EQUIVALENT 2
NIDEK CO
  SUBSTANTIALLY EQUIVALENT 2
OPKO
  SUBSTANTIALLY EQUIVALENT 1
OPTOS PLC
  SUBSTANTIALLY EQUIVALENT 1
OPTOVUE, INC.
  SUBSTANTIALLY EQUIVALENT 4
TOPCON CORP.
  SUBSTANTIALLY EQUIVALENT 4

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

Recalls
Manufacturer Recall Class Date Posted
1 Carl Zeiss Meditec Inc II May-02-2011
2 Optovue Inc. II Oct-09-2012
3 Optovue Inc. II Mar-30-2012
4 Optovue Inc. II Mar-15-2010

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