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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device,analysis,anterior segment
Regulation Description AC-powered slitlamp biomicroscope.
Product CodeMXK
Regulation Number 886.1850
Device Class 2


Premarket Reviews
ManufacturerDecision
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEIDELBERG ENGINEERING
  SUBSTANTIALLY EQUIVALENT 2
OCULUS OPTIKGERATE GMBH
  SUBSTANTIALLY EQUIVALENT 4
SIS LTD. SURGICAL INSTRUMENT SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
WAVELIGHT
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect measurement 1
Total Device Problems 1

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