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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
Regulation Description Suction lipoplasty system.
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
BLACK & BLACK SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CELLMYX
  SUBSTANTIALLY EQUIVALENT 1
LHBIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROAIRE SURGICAL INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 1
MICROAIRE SURGICAL INSTRUMENTS, LLC
  SUBSTANTIALLY EQUIVALENT 3
PUREGRAFT LLC
  SUBSTANTIALLY EQUIVALENT 1
SOLTA MEDICAL
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2022 5 5
2023 28 28
2024 16 16
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 25 25
Break 5 5
Activation Failure 4 4
Communication or Transmission Problem 2 2
Suction Failure 2 2
Patient-Device Incompatibility 2 2
Insufficient Information 2 2
Smoking 2 2
Key or Button Unresponsive/not Working 2 2
Material Fragmentation 2 2
Blocked Connection 2 2
Excessive Heating 2 2
Connection Problem 2 2
Improper or Incorrect Procedure or Method 2 2
No Display/Image 1 1
Output Problem 1 1
Energy Output Problem 1 1
Pumping Stopped 1 1
Battery Problem 1 1
Use of Device Problem 1 1
Decrease in Suction 1 1
Ambient Noise Problem 1 1
Failure to Conduct 1 1
Suction Problem 1 1
Failure of Device to Self-Test 1 1
Complete Loss of Power 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 24 24
Burn(s) 22 22
Scar Tissue 8 8
Partial thickness (Second Degree) Burn 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Necrosis 2 2
Blister 2 2
Skin Discoloration 2 2
Erythema 2 2
Full thickness (Third Degree) Burn 2 2
Abdominal Pain 1 1
Bowel Perforation 1 1
Inflammation 1 1
Anemia 1 1
Cardiac Arrest 1 1
Pleural Effusion 1 1
Septic Shock 1 1
Insufficient Information 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Ecchymosis 1 1
Pain 1 1
Hypoglycemia 1 1
Tachycardia 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Ulcer 1 1
Physical Asymmetry 1 1
No Consequences Or Impact To Patient 1 1
Fibrosis 1 1
Low Blood Pressure/ Hypotension 1 1
Respiratory Failure 1 1
Bruise/Contusion 1 1
Distress 1 1
Lethargy 1 1
Skin Burning Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 HUMAN MED AG II Feb-28-2025
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