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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
2022 4 4
2023 2 2
2024 2 2
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Energy Output Problem 2 2
Crack 1 1
Insufficient Information 1 1
Defective Device 1 1
Contamination /Decontamination Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Sharp Edges 1 1
Appropriate Term/Code Not Available 1 1
Lack of Maintenance Documentation or Guidelines 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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Burn(s) 1 1
Unspecified Eye / Vision Problem 1 1
Insufficient Information 1 1
Laceration(s) 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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