TPLC - Total Product Life Cycle

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Device	powered microneedle device
Regulation Description	Microneedling device for aesthetic use.
Definition	A powered microneedle device is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use.
Product Code	QAI
Regulation Number	878.4430
Device Class	2

Premarket Reviews
Manufacturer	Decision
BOMTECH ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CAMPOMATS S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
CROWN AESTHETICS
	SUBSTANTIALLY EQUIVALENT	3
CYTRELLIS BIOSYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
DERMALOGICA, LLC
	SUBSTANTIALLY EQUIVALENT	1
DERMAROLLER GMBH
	SUBSTANTIALLY EQUIVALENT	1
ECLIPSE MEDCORP, LLC
	SUBSTANTIALLY EQUIVALENT	2
EQUIPMED USA, LLC
	SUBSTANTIALLY EQUIVALENT	1
ESTHETIC MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
GUANGZHOU EKAI ELECTRONIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INDUCTION THERAPIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
MT. DERM GMBH
	SUBSTANTIALLY EQUIVALENT	1
SU-KO TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	2
VENUS CONCEPT USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
WOORHI MECHATRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	21	21
Loss of or Failure to Bond	12	12
Break	11	11
Material Integrity Problem	11	11
Off-Label Use	7	7
Patient-Device Incompatibility	3	3
Use of Device Problem	3	3
Improper or Incorrect Procedure or Method	3	3
Inadequate Instructions for Non-Healthcare Professional	2	3
Patient Device Interaction Problem	2	2
Use of Incorrect Control/Treatment Settings	2	2
Output Problem	1	1
Insufficient Information	1	1
Unclear Information	1	1
Labelling, Instructions for Use or Training Problem	1	1
Product Quality Problem	1	1
Missing Information	1	1
Protective Measures Problem	1	1
Unexpected Therapeutic Results	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	11	11
Skin Discoloration	9	9
Scar Tissue	9	9
Skin Infection	6	6
Erythema	5	5
Swelling/ Edema	5	5
Impaired Healing	4	4
Pain	4	4
Skin Burning Sensation	3	3
Hypersensitivity/Allergic reaction	3	3
Emotional Changes	3	3
Skin Inflammation/ Irritation	3	3
Itching Sensation	3	3
Skin Disorders	3	3
Rash	3	3
Hemorrhage/Bleeding	3	3
Unspecified Tissue Injury	3	4
Localized Skin Lesion	2	2
Skin Erosion	2	2
Deformity/ Disfigurement	2	2
Ptosis	2	2
Discomfort	2	2
Skin Tears	2	2
Wrinkling	2	2
Increased Sensitivity	1	1
Angioedema	1	1
Ambulation Difficulties	1	1
Bruise/Contusion	1	1
Full thickness (Third Degree) Burn	1	1
Low Oxygen Saturation	1	1
Granuloma	1	1
Subcutaneous Nodule	1	1
Bacterial Infection	1	1
Partial thickness (Second Degree) Burn	1	1
Contact Dermatitis	1	1
Fluid Discharge	1	1
Abscess	1	1
Insufficient Information	1	1
Viral Infection	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Needle Stick/Puncture	1	1
Oversedation	1	1
Burn(s)	1	1
Easy Bruising	1	1
Blister	1	1
Anaphylactoid	1	1
Fatigue	1	1
Stroke/CVA	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Unspecified Infection	1	1