• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 CodeQAI
Regulation Number 878.4430
Device Class 2


Premarket Reviews
ManufacturerDecision
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

MDR Year MDR Reports MDR Events
2020 1 1
2021 2 2
2022 6 6
2023 29 29
2024 5 5
2025 3 3

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

Recalls
Manufacturer Recall Class Date Posted
1 Cytrellis Biosystems, Inc. II Aug-11-2023
2 Cytrellis Biosystems, Inc. II May-26-2023
-
-