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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laser, cellulite appearance
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
Definition For the removal of fat through laser lipolysis.
Product CodeOYW
Regulation Number 878.4810
Device Class 2


Premarket Reviews
ManufacturerDecision
CYNOSURE, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Improper or incorrect procedure or method 3
No Known Device Problem 1
Total Device Problems 4

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