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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device laser for disruption of adipocyte cells for aesthetic use
Regulation Description Low level laser system for aesthetic use
Definition Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.
Product CodePKT
Regulation Number 878.5400
Device Class 2


Premarket Reviews
ManufacturerDecision
DOMINION AESTHETIC TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
EL.EN S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
HEBEI JT MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HIRONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIGHTFECTIVE , LTD.
  SUBSTANTIALLY EQUIVALENT 1
LOTUXS MEDTECH (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ROHRER AESTHETICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI BELE MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI WONDERFUL OPTO-ELECTRICS TECH.CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1

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