TPLC - Total Product Life Cycle

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Device	light, ultraviolet, dermatological
Product Code	FTC
Regulation Number	878.4630
Device Class	2

Premarket Reviews
Manufacturer	Decision
CHONGQING PENINSULA MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CLARTEIS
	SUBSTANTIALLY EQUIVALENT	1
DAAVLIN DISTRIBUTING CO.
	SUBSTANTIALLY EQUIVALENT	5
PSORIA-SHIELD
	SUBSTANTIALLY EQUIVALENT	1
PSORIA-SHIELD, INC.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN GSD 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	2
XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY 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	18	18
Adverse Event Without Identified Device or Use Problem	18	18
Inadequate Instructions for Non-Healthcare Professional	9	9
Improper or Incorrect Procedure or Method	6	6
Product Quality Problem	4	4
Use of Incorrect Control/Treatment Settings	2	2
Defective Component	2	2
Energy Output Problem	2	2
Device Markings/Labelling Problem	2	2
Output Problem	2	2
Patient Device Interaction Problem	2	2
Excessive Heating	1	1
Radiation Overexposure	1	1
Therapeutic or Diagnostic Output Failure	1	1
Appropriate Term/Code Not Available	1	1
Inadequate User Interface	1	1
No Fail-Safe Mechanism	1	1
Application Program Problem	1	1
Calibration Problem	1	1
Display Difficult to Read	1	1
Labelling, Instructions for Use or Training Problem	1	1
Device Appears to Trigger Rejection	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burn, Thermal	22	22
Skin Irritation	10	10
No Known Impact Or Consequence To Patient	10	10
Burn(s)	9	9
Itching Sensation	8	8
Radiation Burn	8	8
Burning Sensation	8	8
Partial thickness (Second Degree) Burn	7	7
Pain	4	4
Erythema	4	4
Superficial (First Degree) Burn	3	3
Blister	2	2
Skin Burning Sensation	2	2
Insufficient Information	2	2
Peeling	2	2
Rash	2	2
Skin Discoloration	2	2
Hemorrhage/Bleeding	2	2
Irritation	2	2
Therapeutic Response, Decreased	1	1
Skin Inflammation	1	1
Skin Tears	1	1
Local Reaction	1	1
Hair Loss	1	1
Headache	1	1
Death	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Skin Inflammation/ Irritation	1	1
Eczema	1	1
Swelling	1	1

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