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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device low power electrosurgical devices for skin lesion destruction
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Definition For the removal and destruction of skin lesions in general dermatological procedures, also referred to as Plasma Pen Devices, which generates electrical arc in the ambient air between an electrical probe tip and the skin and cause intended tissue damage for the removal and destruction of skin lesions
Product CodeQVJ
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
COMPEX, SPOL, S.R.O.
  SUBSTANTIALLY EQUIVALENT 1
GCS CO. LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PLASMA CONCEPTS
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN LEAFLIFE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

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