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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dermal cooling pack/vacuum/massager
Regulation Description Contact cooling system for aesthetic use.
Definition The device is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disruption or induction of adipocyte cells indicated for body contouring or reduction in circumference of body areas.
Product CodeOOK
Regulation Number 878.4340
Device Class 2


Premarket Reviews
ManufacturerDecision
ZELTIQ AESTHETICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZELTIQ AESTHETICS, INC. (ACQUIRED BY ALLERGAN AESTHETICS
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Zeltiq Aesthetics, Inc II Jul-11-2022
2 Zeltiq Aesthetics, Inc II Aug-27-2021
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