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	1
DERMAROLLER GMBH
	SUBSTANTIALLY EQUIVALENT	1
ECLIPSE MEDCORP LLC
	SUBSTANTIALLY EQUIVALENT	1
ECLIPSE MEDCORP, LLC
	SUBSTANTIALLY EQUIVALENT	1
EQUIPMED USA LLC
	SUBSTANTIALLY EQUIVALENT	1
ESTHETIC EDUCATION LLC
	SUBSTANTIALLY EQUIVALENT	1
ESTHETIC MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU EKAI ELECTRONIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INDUCTION THERAPIES LLC
	SUBSTANTIALLY EQUIVALENT	1
MT.DERM GMBH
	SUBSTANTIALLY EQUIVALENT	1
REFINE USA LLC
	SUBSTANTIALLY EQUIVALENT	1
SU-KO TECHNOLOGIES LLC
	SUBSTANTIALLY EQUIVALENT	1
VENUS CONCEPT USA INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	15	15
Loss of or Failure to Bond	12	12
Break	11	11
Material Integrity Problem	11	11
Off-Label Use	3	3
Patient-Device Incompatibility	3	3
Use of Device Problem	3	3
Inadequate Instructions for Non-Healthcare Professional	2	2
Use of Incorrect Control/Treatment Settings	2	2
Improper or Incorrect Procedure or Method	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	10	10
Impaired Healing	5	5
Scar Tissue	5	5
Erythema	4	4
Skin Infection	3	3
Skin Burning Sensation	3	3
Hemorrhage/Bleeding	3	3
Pain	3	3
Unspecified Tissue Injury	3	3
Swelling/ Edema	3	3
Hypersensitivity/Allergic reaction	2	2
Emotional Changes	2	2
Localized Skin Lesion	2	2
Rash	2	2
Skin Erosion	2	2
Ptosis	2	2
Discomfort	2	2
Skin Tears	2	2
Increased Sensitivity	1	1
Angioedema	1	1
Ambulation Difficulties	1	1
Bruise/Contusion	1	1
Granuloma	1	1
Low Oxygen Saturation	1	1
Subcutaneous Nodule	1	1
Bacterial Infection	1	1
Deformity/ Disfigurement	1	1
Contact Dermatitis	1	1
Wrinkling	1	1
Abscess	1	1
Fluid Discharge	1	1
Viral Infection	1	1
Insufficient Information	1	1
Oversedation	1	1
Itching Sensation	1	1
Anaphylactoid	1	1
Cyst(s)	1	1
Skin Inflammation/ Irritation	1	1
Fatigue	1	1
Stroke/CVA	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Unspecified Infection	1	1