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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrosurgical coagulation for aesthetic
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Definition For the treatment of spider vein or telangiectasia by thermocoagulation.
Product CodeONQ
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
F CARE SYSTEMS USA, LLC
  SUBSTANTIALLY EQUIVALENT 1

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