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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device massager, vacuum, radio frequency induced heat
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Definition Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.
Product CodePBX
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOS S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
CUTERA, INC.
  SUBSTANTIALLY EQUIVALENT 2
ELLMAN INT'L INC.
  SUBSTANTIALLY EQUIVALENT 1

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