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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device booth, sun tan
Product CodeLEJ
Regulation Number 878.4635
Device Class 2


Premarket Reviews
ManufacturerDecision
JK-HOLDING GMBH
  SUBSTANTIALLY EQUIVALENT 3
KBL GMBH
  SUBSTANTIALLY EQUIVALENT 1
UNILAM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 3 3
2022 4 4
2023 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Energy Output Problem 2 2
Defective Device 1 1
Contamination /Decontamination Problem 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Temperature Problem 1 1
Insufficient Information 1 1
Sharp Edges 1 1
Crack 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 Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Radiation Burn 1 1
Burn(s) 1 1
Conjunctivitis 1 1
Itching Sensation 1 1
Laceration(s) 1 1
Burn, Thermal 1 1

Recalls
Manufacturer Recall Class Date Posted
1 J&T Health and Wellness LLC II Sep-28-2023
2 ProSun International, LLC II Apr-16-2019
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