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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device light, ultraviolet, dermatological
Product CodeFTC
Regulation Number 878.4630
Device Class 2


Premarket Reviews
ManufacturerDecision
CHONGQING PENINSULA MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CLARTEIS
  SUBSTANTIALLY EQUIVALENT 2
DAAVLIN DISTRIBUTING CO.
  SUBSTANTIALLY EQUIVALENT 3
DAAVLIN DISTRIBUTING COMPANY
  SUBSTANTIALLY EQUIVALENT 1
LUMA THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 1
PSORIA-SHIELD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN GSD TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SKYLIT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ULTRASUN INTERNATIONAL B.V.
  SUBSTANTIALLY EQUIVALENT 1
XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 2 2
2019 14 14
2020 4 4
2021 48 48
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 23 23
Use of Device Problem 18 18
Adverse Event Without Identified Device or Use Problem 16 16
Inadequate Instructions for Non-Healthcare Professional 9 9
Improper or Incorrect Procedure or Method 6 6
Product Quality Problem 4 4
Defective Component 2 2
Device Markings/Labelling Problem 2 2
Patient Device Interaction Problem 2 2
Excessive Heating 1 1
Device Operational Issue 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Appropriate Term/Code Not Available 1 1
Calibration Problem 1 1
Device Appears to Trigger Rejection 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Labelling, Instructions for Use or Training Problem 1 1
Energy Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn, Thermal 23 23
No Known Impact Or Consequence To Patient 10 10
Skin Irritation 10 10
Burning Sensation 8 8
Radiation Burn 7 7
Burn(s) 7 7
Itching Sensation 7 7
Partial thickness (Second Degree) Burn 5 5
Erythema 4 4
Pain 3 3
Hemorrhage/Bleeding 2 2
Irritation 2 2
Rash 2 2
Blister 2 2
Skin Burning Sensation 2 2
Insufficient Information 2 2
Skin Discoloration 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Eczema 1 1
Radiation Exposure, Unintended 1 1
Local Reaction 1 1
Swelling 1 1
Therapeutic Response, Decreased 1 1
Skin Inflammation 1 1
Skin Tears 1 1
Peeling 1 1
Hair Loss 1 1
Headache 1 1
Death 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Daavlin Distributing Company II May-12-2022
2 National Biological Corp II Mar-20-2017
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