TPLC - Total Product Life Cycle

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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
BIMINI HEALTH TECH
	SUBSTANTIALLY EQUIVALENT	1
BSL CO.
	SUBSTANTIALLY EQUIVALENT	1
EUROMI S.A
	SUBSTANTIALLY EQUIVALENT	1
HSINGCHI MEDICAL LTD.
	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
STEMC BIOTECHNOLOGY INC
	SUBSTANTIALLY EQUIVALENT	1
SYNOVA LIFE SCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	1
SYNTR HEALTH TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	26	26
Suction Problem	12	12
Output Problem	11	11
Break	7	7
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
Infusion or Flow Problem	2	2
Fluid/Blood Leak	2	2
Pressure Problem	1	1
Device Tipped Over	1	1
Patient-Device Incompatibility	1	1
Backflow	1	1
Component Missing	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	65	65
Insufficient Information	4	4
Unspecified Infection	3	3
Inflammation	3	3
Post Operative Wound Infection	3	3
Bacterial Infection	1	1