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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
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
CYNOSURE
  SUBSTANTIALLY EQUIVALENT 1
DOMINION AESTHETIC TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
EL.EN. S.P.A
  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
WUHAN LOTUXS TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 13 13
2020 5 5
2021 6 6
2022 4 4
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 20 20
Use of Device Problem 5 5
Patient-Device Incompatibility 3 3
Improper or Incorrect Procedure or Method 1 1
Output below Specifications 1 1
Unexpected/Unintended Radiation Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Patient Problem/Medical Problem 9 9
Nodule 7 7
Pain 3 3
Burn(s) 2 2
No Consequences Or Impact To Patient 2 2
Swelling/ Edema 2 2
No Code Available 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Burn, Thermal 1 1
Cellulitis 1 1
Erythema 1 1
Pleural Effusion 1 1
Scar Tissue 1 1
Swelling 1 1

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