TPLC - Total Product Life Cycle

• Device: lamp, infrared, therapeutic heating
• Product Code: ILY
• Regulation Number: 890.5500
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AESTHETIC TECHNOLOGY LTD
	SUBSTANTIALLY EQUIVALENT	1
CYTONSYS INC
	SUBSTANTIALLY EQUIVALENT	1
LIGHT TREE VENTURES EUROPE B.V.
	SUBSTANTIALLY EQUIVALENT	1
LTBIO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	1	1
2019	7	7
2020	5	5
2021	5	5
2022	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	4	4
Overheating of Device	3	3
Patient-Device Incompatibility	3	3
Improper or Incorrect Procedure or Method	2	2
Defective Device	1	1
Device Operational Issue	1	1
Break	1	1
Electrical /Electronic Property Problem	1	1
Labelling, Instructions for Use or Training Problem	1	1
Device Emits Odor	1	1
Power Problem	1	1
Temperature Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	4	4
Partial thickness (Second Degree) Burn	3	3
Rash	2	2
Radiation Burn	2	2
Headache	2	2
Inflammation	2	2
Nausea	1	1
Pain	1	1
Bruise/Contusion	1	1
Red Eye(s)	1	1
Dizziness	1	1
Complaint, Ill-Defined	1	1
Sore Throat	1	1
Reaction	1	1
Numbness	1	1
Skin Inflammation	1	1
Burn, Thermal	1	1
Radiation Exposure, Unintended	1	1
Swollen Lymph Nodes/Glands	1	1
Unspecified Respiratory Problem	1	1
Unspecified Eye / Vision Problem	1	1
Blister	1	1
Insufficient Information	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Inlightened Partners LLC	III	Jun-24-2021