TPLC - Total Product Life Cycle

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Device	lamp, infrared, therapeutic heating
Regulation Description	Infrared lamp.
Product Code	ILY
Regulation Number	890.5500
Device Class	2

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Excessive Heating	19	19
Adverse Event Without Identified Device or Use Problem	8	8
Use of Device Problem	3	3
Overheating of Device	2	2
Insufficient Information	2	2
Patient-Device Incompatibility	2	2
Labelling, Instructions for Use or Training Problem	1	1
Device Emits Odor	1	1
Power Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Physical Resistance/Sticking	1	1
Failure to Clean Adequately	1	1
Break	1	1
Unintended Power Up	1	1
Electrical /Electronic Property Problem	1	1
Device Markings/Labelling Problem	1	1
Device Operational Issue	1	1
Device-Device Incompatibility	1	1
Difficult to Open or Close	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burning Sensation	12	12
No Clinical Signs, Symptoms or Conditions	8	8
Erythema	4	4
Headache	4	4
Skin Burning Sensation	4	4
No Known Impact Or Consequence To Patient	4	4
Partial thickness (Second Degree) Burn	4	4
Chest Pain	3	3
Blister	3	3
Dizziness	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Insufficient Information	2	2
Swelling/ Edema	2	2
Unspecified Gastrointestinal Problem	2	2
Rash	2	2
Unspecified Respiratory Problem	2	2
Superficial (First Degree) Burn	2	2
Skin Inflammation/ Irritation	1	1
Localized Skin Lesion	1	1
Unspecified Eye / Vision Problem	1	1
Swollen Lymph Nodes/Glands	1	1
Tics/Tremor	1	1
Convulsion/Seizure	1	1
Dementia	1	1
Radiation Exposure, Unintended	1	1
Full thickness (Third Degree) Burn	1	1
Numbness	1	1
Sore Throat	1	1
Inadequate Pain Relief	1	1
Discomfort	1	1
Viral Infection	1	1
Scar Tissue	1	1
Red Eye(s)	1	1
Undesired Nerve Stimulation	1	1
Necrosis	1	1
Nausea	1	1
Inflammation	1	1
Hemorrhage/Bleeding	1	1
Eye Injury	1	1
Dyspnea	1	1
Bruise/Contusion	1	1
Aspiration/Inhalation	1	1