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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lamp, infrared, therapeutic heating
Regulation Description Infrared lamp.
Product CodeILY
Regulation Number 890.5500
Device Class 2


Premarket Reviews
ManufacturerDecision
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
WUHAN PHOMED TECHNOLOGY COMPANY , LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 5 5
2022 2 3
2023 15 15
2024 19 19
2025 17 17
2026 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Excessive Heating 19 19
Temperature Problem 12 12
Adverse Event Without Identified Device or Use Problem 3 3
Use of Device Problem 3 3
Insufficient Device Problem Information 2 2
Difficult to Open or Close 1 1
Device Handling Problem 1 1
Break 1 1
Device-Device Incompatibility 1 1
Smoking 1 1
Unintended Power Up 1 1
Physical Resistance/Sticking 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burning Sensation 13 13
Burn(s) 12 12
No Clinical Signs, Symptoms or Conditions 10 10
Skin Burning Sensation 5 5
Superficial (First Degree) Burn 5 5
Headache 4 5
Erythema 4 4
Partial thickness (Second Degree) Burn 4 4
Swelling/ Edema 3 3
Dizziness 3 4
Insufficient Information 3 3
Chest Pain 3 3
Rash 3 3
Blister 3 3
Eye Injury 2 2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 2
Unspecified Respiratory Problem 2 3
Numbness 2 2
Limb Pain 2 2
Hemorrhage/Blood Loss/Bleeding 2 2
Unspecified Gastrointestinal Problem 2 2
Nausea 1 2
Joint effusion 1 1
Unspecified Eye / Vision Problem 1 2
Discomfort 1 1
Inflammation 1 2
Hypoxia 1 1
Scar Tissue 1 1
Dementia 1 1
Red Eye(s) 1 2
Dyspnea 1 1
Swollen Lymph Nodes/Glands 1 2
Undesired Nerve Stimulation 1 1
Convulsion/Seizure 1 1
Necrosis 1 1
Sore Throat 1 2
High Blood Pressure/ Hypertension 1 1
Eye Burn 1 1
Vitreous Hemorrhage 1 1
Deformity/ Disfigurement 1 1
Pain 1 1
Aspiration/Inhalation 1 1
Loss of Vision 1 1
Full thickness (Third Degree) Burn 1 1
Viral Infection 1 1
Tics/Tremor 1 1
Inadequate Pain Relief 1 1
Radiation Burn 1 1
Skin Inflammation/ Irritation 1 1
Localized Skin Lesion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Inlightened Partners LLC III Jun-24-2021
2 MITO RED LIGHT INC II Jun-17-2026
3 THOR Photomedicine Ltd II Aug-22-2025
4 THOR Photomedicine Ltd II Feb-01-2024
5 Technological Medical Advancements LLC II May-11-2026
6 Thor Photomedicine Ltd II Dec-01-2023
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