TPLC - Total Product Life Cycle

• Device: lipoaspirate washing system for aesthetic body contouring
• Regulation Description: Suction lipoplasty system.
• Definition: Wash, filter, concentrate, and or fragment autologous adipose tissue aspirated via liposuction for aesthetic body contouring without further manipulation
• Product Code: QKL
• Regulation Number: 878.5040
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ALMA LASERS, INC
	SUBSTANTIALLY EQUIVALENT	1
BSL CO.
	SUBSTANTIALLY EQUIVALENT	1
LIFECELL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MICROAIRE SURGICAL INSTRUMENTS, LLC.
	SUBSTANTIALLY EQUIVALENT	1
MILLENNIUM MEDICAL TECHNOLOGIES INC (DBA CELLMYX)
	SUBSTANTIALLY EQUIVALENT	1
MUSCULOSKELETAL TRANSPLANT FOUNDATION
	SUBSTANTIALLY EQUIVALENT	1
PUREGRAFT LLC
	SUBSTANTIALLY EQUIVALENT	1
STEMC BIOTECHNOLOGY INC
	SUBSTANTIALLY EQUIVALENT	1
SYNTR HEALTH TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
TIGER AESTHETICS MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2023	18	18
2024	25	25
2025	10	10

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	13	13
Output Problem	10	10
Suction Problem	6	6
Break	5	5
Patient Device Interaction Problem	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Device Contamination with Chemical or Other Material	3	3
Crack	2	2
Pressure Problem	1	1
Device Tipped Over	1	1
Patient-Device Incompatibility	1	1
Backflow	1	1
Component Missing	1	1
Infusion or Flow Problem	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	44	44
Unspecified Infection	3	3
Inflammation	3	3
Post Operative Wound Infection	3	3
Insufficient Information	2	2
Bacterial Infection	1	1