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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device laser for disruption of adipocyte cells for aesthetic use
Regulation Description Low level laser system for aesthetic use
Definition Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.
Product CodePKT
Regulation Number 878.5400
Device Class 2


Premarket Reviews
ManufacturerDecision
CYNOSURE, INC.
  SUBSTANTIALLY EQUIVALENT 4
WUHAN LOTUXS TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 31
Use of Device Problem 4
Device Component Or Accessory 2
Diode 1
Applicator 1
Handpiece 1
Device Displays Incorrect Message 1
Laser 1
Output below Specifications 1
Unexpected/Unintended Radiation Output 1
Total Device Problems 44


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