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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 booth, sun tan
Regulation Description Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
Product CodeLEJ
Regulation Number 878.4635
Device Class 2


Premarket Reviews
ManufacturerDecision
JK-HOLDING GMBH
  SUBSTANTIALLY EQUIVALENT 1
UNILAM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 3 3
2022 4 4
2023 2 2
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Energy Output Problem 2 2
Crack 1 1
Insufficient Information 1 1
Defective Device 1 1
Contamination /Decontamination Problem 1 1
Sharp Edges 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Partial thickness (Second Degree) Burn 2 2
Full thickness (Third Degree) Burn 2 2
Ambulation Difficulties 2 2
Superficial (First Degree) Burn 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Burn, Thermal 1 1
No Known Impact Or Consequence To Patient 1 1
Burn(s) 1 1
Conjunctivitis 1 1
Insufficient Information 1 1
Unspecified Eye / Vision Problem 1 1
Laceration(s) 1 1
Radiation Burn 1 1
Increased Sensitivity 1 1

Recalls
Manufacturer Recall Class Date Posted
1 J&T Health and Wellness LLC II Sep-28-2023
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