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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device powered surgical instrument for improvement in the appearance of cellulite
Regulation Description Powered surgical instrument for improvement in the appearance of cellulite.
Definition Used for controlled release of subcutaneous tissue for improvement in the appearance of cellulite.
Product CodeOUP
Regulation Number 878.4790
Device Class 2


Premarket Reviews
ManufacturerDecision
CABOCHON AESTHETICS, INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1
ULTHERA, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
No Known Device Problem 2
Total Device Problems 2

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