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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device powered microneedle device
Definition A powered microneedle device is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use.
Product CodeQAI
Regulation Number 878.4430
Device Class 2


Premarket Reviews
ManufacturerDecision
BELLUS MEDICAL, LLC.
  GRANTED 1
CROWN AESTHETICS
  SUBSTANTIALLY EQUIVALENT 2
CYTRELLIS BIOSYSTEMS, INC.
  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
MT.DERM GMBH
  SUBSTANTIALLY EQUIVALENT 1
REFINE USA LLC
  SUBSTANTIALLY EQUIVALENT 1
VENUS CONCEPT USA INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 2 2
2022 6 6
2023 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Loss of or Failure to Bond 12 12
Break 11 11
Material Integrity Problem 11 11
Adverse Event Without Identified Device or Use Problem 10 10
Inadequate Instructions for Non-Healthcare Professional 2 2
Output Problem 1 1
Protective Measures Problem 1 1
Insufficient Information 1 1
Unclear Information 1 1
Missing Information 1 1
Labelling, Instructions for Use or Training Problem 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Unexpected Therapeutic Results 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
Skin Discoloration 6 6
Impaired Healing 5 5
Scar Tissue 3 3
Pain 2 2
Hemorrhage/Bleeding 2 2
Erythema 2 2
Skin Infection 2 2
Skin Tears 2 2
Unspecified Tissue Injury 2 2
Swelling/ Edema 2 2
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Ambulation Difficulties 1 1
Wrinkling 1 1
Fluid Discharge 1 1
Skin Burning Sensation 1 1
Localized Skin Lesion 1 1
Skin Inflammation/ Irritation 1 1
Low Oxygen Saturation 1 1
Fatigue 1 1
Bruise/Contusion 1 1
Cyst(s) 1 1
Unspecified Infection 1 1
Oversedation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bellus Medical II Dec-09-2019
2 Cytrellis Biosystems, Inc. II Aug-11-2023
3 Cytrellis Biosystems, Inc. II May-26-2023
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