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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device light based over the counter wrinkle reduction
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
Definition Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.
Product CodeOHS
Regulation Number 878.4810
Device Class 2


Premarket Reviews
ManufacturerDecision
CYNOSURE, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOME SKINOVATIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
LED INTELLECTUAL PROPERTIES, LLC
  SUBSTANTIALLY EQUIVALENT 2
LED TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
LIGHT BIOSCIENCE, LLC
  SUBSTANTIALLY EQUIVALENT 1
PHAROS LIFE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PHOTO THERAPEUTICS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SILVER BAY, LLC
  SUBSTANTIALLY EQUIVALENT 1

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 1 0 0 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Sybaritic, Inc II Apr-30-2009

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