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TPLC
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show TPLC since
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Device
lamp, infrared, therapeutic heating
Regulation Description
Infrared lamp.
Product Code
ILY
Regulation Number
890.5500
Device Class
2
Premarket Reviews
Manufacturer
Decision
AESTHETIC TECHNOLOGY LTD
SUBSTANTIALLY EQUIVALENT
1
CURE POINT THERAPEUTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
CYTONSYS INC
SUBSTANTIALLY EQUIVALENT
1
GIGAALASER COMPANY LTD.
SUBSTANTIALLY EQUIVALENT
1
LIGHT TREE VENTURES EUROPE B.V.
SUBSTANTIALLY EQUIVALENT
1
LTBIO CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
5
5
2021
5
5
2022
2
2
2023
15
15
2024
19
19
2025
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
Excessive Heating
19
19
Adverse Event Without Identified Device or Use Problem
8
8
Use of Device Problem
3
3
Overheating of Device
2
2
Insufficient Information
2
2
Patient-Device Incompatibility
2
2
Labelling, Instructions for Use or Training Problem
1
1
Device Emits Odor
1
1
Power Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Physical Resistance/Sticking
1
1
Failure to Clean Adequately
1
1
Break
1
1
Unintended Power Up
1
1
Electrical /Electronic Property Problem
1
1
Device Markings/Labelling Problem
1
1
Device Operational Issue
1
1
Device-Device Incompatibility
1
1
Difficult to Open or Close
1
1
Improper or Incorrect Procedure or Method
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Burning Sensation
12
12
No Clinical Signs, Symptoms or Conditions
8
8
Erythema
4
4
Headache
4
4
Skin Burning Sensation
4
4
No Known Impact Or Consequence To Patient
4
4
Partial thickness (Second Degree) Burn
4
4
Chest Pain
3
3
Blister
3
3
Dizziness
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Insufficient Information
2
2
Swelling/ Edema
2
2
Unspecified Gastrointestinal Problem
2
2
Rash
2
2
Unspecified Respiratory Problem
2
2
Superficial (First Degree) Burn
2
2
Skin Inflammation/ Irritation
1
1
Localized Skin Lesion
1
1
Unspecified Eye / Vision Problem
1
1
Swollen Lymph Nodes/Glands
1
1
Tics/Tremor
1
1
Convulsion/Seizure
1
1
Dementia
1
1
Radiation Exposure, Unintended
1
1
Full thickness (Third Degree) Burn
1
1
Numbness
1
1
Sore Throat
1
1
Inadequate Pain Relief
1
1
Discomfort
1
1
Viral Infection
1
1
Scar Tissue
1
1
Red Eye(s)
1
1
Undesired Nerve Stimulation
1
1
Necrosis
1
1
Nausea
1
1
Inflammation
1
1
Hemorrhage/Bleeding
1
1
Eye Injury
1
1
Dyspnea
1
1
Bruise/Contusion
1
1
Aspiration/Inhalation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Inlightened Partners LLC
III
Jun-24-2021
2
THOR Photomedicine Ltd
II
Feb-01-2024
3
Thor Photomedicine Ltd
II
Dec-01-2023
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