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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device light, ultraviolet, dermatological
Regulation Description Ultraviolet lamp for dermatologic disorders.
Product CodeFTC
Regulation Number 878.4630
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLUX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CYNOSURE, INC.
  SUBSTANTIALLY EQUIVALENT 1
DAAVLIN
  SUBSTANTIALLY EQUIVALENT 10
DIOMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LERNER MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 3
LIGHT SOURCES, INC.
  SUBSTANTIALLY EQUIVALENT 8
LUMENIS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDICAL DEVICE CONSULTANTS, INC.
  SUBSTANTIALLY EQUIVALENT 4
NATIONAL BIOLOGICAL CORP.
  SUBSTANTIALLY EQUIVALENT 26
SOLARC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
THERALIGHT, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Improper or incorrect procedure or method 3
Use of Device Issue 2
No Known Device Problem 1
No Information 1
Use of Incorrect Control Settings 1
Inadequate training 1
Total Device Problems 9

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

Recalls
Manufacturer Recall Class Date Posted
1 National Biological Corp III Jul-19-2013
2 National Biological Corp III Jul-19-2013
3 National Biological Corp III Aug-28-2008

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