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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, suction, lipoplasty for removal
Definition A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring
Product CodeQPB
Regulation Number 878.5040
Device Class 2


Premarket Reviews
ManufacturerDecision
MICROAIRE SURGICAL INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 1
MICROAIRE SURGICAL INSTRUMENTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
PUREGRAFT LLC
  SUBSTANTIALLY EQUIVALENT 1
SOLTA MEDICAL
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2022 4 4
2023 28 28
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 21 21
Break 3 3
Patient-Device Incompatibility 2 2
Smoking 2 2
Connection Problem 2 2
Excessive Heating 2 2
Failure of Device to Self-Test 1 1
Output Problem 1 1
Complete Loss of Power 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Suction Problem 1 1
Ambient Noise Problem 1 1
Failure to Conduct 1 1
Energy Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 19 19
No Clinical Signs, Symptoms or Conditions 10 10
Scar Tissue 5 5
Skin Discoloration 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Erythema 2 2
Partial thickness (Second Degree) Burn 2 2
Full thickness (Third Degree) Burn 1 1
Fibrosis 1 1
Blister 1 1
Skin Burning Sensation 1 1
Unspecified Tissue Injury 1 1
Inflammation 1 1
Necrosis 1 1
Pain 1 1
Bruise/Contusion 1 1
Bowel Perforation 1 1

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