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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lasers for temporary increase of clear nail in patients with onychomycosis
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
Definition For the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).
Product CodePDZ
Regulation Number 878.4810
Device Class 2


Premarket Reviews
ManufacturerDecision
BLUESHINE SRL
  SUBSTANTIALLY EQUIVALENT 1
CUTERA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ERCHONIA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FOTONA D.D.
  SUBSTANTIALLY EQUIVALENT 2
LITECURE, LLC
  SUBSTANTIALLY EQUIVALENT 1
LUTRONIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NEW STAR LASERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCITON, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Hyperion Medical II Aug-18-2014

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