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TPLC
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show TPLC since
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2024
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Device
booth, sun tan
Product Code
LEJ
Regulation Number
878.4635
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
2
2
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
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 Known Impact Or Consequence To Patient
1
1
Unspecified Eye / Vision Problem
1
1
Increased Sensitivity
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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