TPLC - Total Product Life Cycle

• Device: laser for disruption of adipocyte cells for aesthetic use
• Regulation Description: Low level laser system for aesthetic use
• Definition: Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.
• Product Code: PKT
• Regulation Number: 878.5400
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
DOMINION AESTHETIC TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
EL.EN. S.P.A
	SUBSTANTIALLY EQUIVALENT	1
HEBEI JT MEDICAL CO., LTD.
	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

MDR Year	MDR Reports	MDR Events
2020	5	5
2021	6	6
2022	4	4
2024	4	4
2025	4	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	15	15
Use of Device Problem	3	3
Improper or Incorrect Procedure or Method	2	2
Material Puncture/Hole	1	1
Insufficient Information	1	1
Smoking	1	1
Material Twisted/Bent	1	1
Insufficient Heating	1	1
Melted	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Nodule	7	7
Burn(s)	4	4
Patient Problem/Medical Problem	3	3
Pain	2	2
Swelling/ Edema	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Clinical Signs, Symptoms or Conditions	1	1
Burn, Thermal	1	1
Cellulitis	1	1
Burning Sensation	1	1
Erythema	1	1
Pleural Effusion	1	1
Scar Tissue	1	1