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	19	19
Loss of or Failure to Bond	12	12
Break	11	11
Material Integrity Problem	11	11
Off-Label Use	7	7
Unclear Information	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Patient Device Interaction Problem	1	1
Insufficient Device Problem Information	1	1
Labelling, Instructions for Use or Training Problem	1	1
Missing Information	1	1
Improper or Incorrect Procedure or Method	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
Hyperpigmentation	6	6
Erythema	6	6
Pain	5	5
Swelling/ Edema	5	5
Impaired Healing	4	4
Skin Burning Sensation	4	4
Skin Inflammation/ Irritation	4	4
Hypersensitivity/Allergic reaction	3	3
Emotional Changes	3	3
Itching Sensation	3	3
Skin Disorders	3	3
Rash	3	3
Hemorrhage/Blood Loss/Bleeding	3	3
Unspecified Tissue Injury	3	4
Unspecified Infection	2	2
Localized Skin Lesion	2	2
Skin Erosion	2	2
Ptosis	2	2
Deformity/ Disfigurement	2	2
Discomfort	2	2
Skin Tears	2	2
Wrinkling	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1
Angioedema	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
Hyperresponsive to stimuli	1	1
Bacterial Infection	1	1
Partial thickness (Second Degree) Burn	1	1
Dry Skin	1	1
Contact Dermatitis	1	1
Fluid Discharge	1	1
Anaphylactoid / Anaphylaxis	1	1
Abscess	1	1
Insufficient Information	1	1
Unspecified Eye / Vision Problem	1	1
Ambulation or Postural Difficulties	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