TPLC - Total Product Life Cycle

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Device	light, ultraviolet, dermatological
Regulation Description	Ultraviolet lamp for dermatologic disorders.
Product Code	FTC
Regulation Number	878.4630
Device Class	2

Premarket Reviews
Manufacturer	Decision
APK TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON AESTHETICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CHOYANG MEDICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DAAVLIN DISTRIBUTING CO.
	SUBSTANTIALLY EQUIVALENT	5
PSORIA-SHIELD, INC.
	SUBSTANTIALLY EQUIVALENT	1
RADCLIFFE WATTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI SIGMA HIGH-TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN HONPAL OPTOELECTRONIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ULTRASUN INTERNATIONAL B.V.
	SUBSTANTIALLY EQUIVALENT	1
XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Patient-Device Incompatibility	23	23
Use of Device Problem	19	19
Adverse Event Without Identified Device or Use Problem	17	17
Patient Device Interaction Problem	7	7
Improper or Incorrect Procedure or Method	5	5
Use of Incorrect Control/Treatment Settings	5	5
Product Quality Problem	4	4
Inadequate Instructions for Non-Healthcare Professional	4	4
Inadequate User Interface	2	2
Output Problem	2	2
Radiation Overexposure	2	2
Therapeutic or Diagnostic Output Failure	1	1
Excessive Heating	1	1
Protective Measures Problem	1	1
No Fail-Safe Mechanism	1	1
Application Program Problem	1	1
Device Markings/Labelling Problem	1	1
Human-Device Interface Problem	1	1
Device Appears to Trigger Rejection	1	1
Display Difficult to Read	1	1
Labelling, Instructions for Use or Training Problem	1	1
Energy Output Problem	1	1
Off-Label Use	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burn, Thermal	22	22
Burn(s)	12	12
Partial thickness (Second Degree) Burn	12	12
Radiation Burn	9	9
Skin Irritation	8	8
Itching Sensation	8	8
Superficial (First Degree) Burn	7	7
Burning Sensation	7	7
Erythema	6	6
Pain	6	6
Blister	3	3
Skin Discoloration	3	3
Insufficient Information	3	3
Fatigue	2	2
No Clinical Signs, Symptoms or Conditions	2	2
Purulent Discharge	2	2
Irritation	2	2
Rash	2	2
Discomfort	2	2
Peeling	2	2
Hemorrhage/Bleeding	2	2
Skin Burning Sensation	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Death	1	1
Skin Inflammation/ Irritation	1	1
Local Reaction	1	1
Skin Inflammation	1	1
Anxiety	1	1
Skin Tears	1	1
Eczema	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Daavlin Distributing Company	II	May-12-2022