Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
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
1. K231997
SIRONA 100 Therapy Laser System (OEM's Model EVANL
...
CYTONSYS INC
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
Device Problems
MDRs with this Device Problem
Events in those MDRs
Excessive Heating
16
16
Adverse Event Without Identified Device or Use Problem
7
7
Patient-Device Incompatibility
2
2
Overheating of Device
2
2
Insufficient Information
2
2
Use of Device Problem
2
2
Power Problem
1
1
Electrical /Electronic Property Problem
1
1
Device Emits Odor
1
1
Labelling, Instructions for Use or Training Problem
1
1
Physical Resistance/Sticking
1
1
Break
1
1
Device Operational Issue
1
1
Improper or Incorrect Procedure or Method
1
1
Device-Device Incompatibility
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Burning Sensation
12
12
No Clinical Signs, Symptoms or Conditions
7
7
Headache
4
4
Partial thickness (Second Degree) Burn
4
4
No Known Impact Or Consequence To Patient
4
4
Chest Pain
3
3
Blister
3
3
Dizziness
3
3
Swelling/ Edema
2
2
Insufficient Information
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Superficial (First Degree) Burn
2
2
Unspecified Respiratory Problem
2
2
Bruise/Contusion
1
1
Radiation Exposure, Unintended
1
1
Aspiration/Inhalation
1
1
Rash
1
1
Red Eye(s)
1
1
Sore Throat
1
1
Inflammation
1
1
Swollen Lymph Nodes/Glands
1
1
Skin Inflammation/ Irritation
1
1
Undesired Nerve Stimulation
1
1
Convulsion/Seizure
1
1
Numbness
1
1
Localized Skin Lesion
1
1
Scar Tissue
1
1
Skin Burning Sensation
1
1
Erythema
1
1
Nausea
1
1
Discomfort
1
1
Dyspnea
1
1
Unspecified Eye / Vision Problem
1
1
Necrosis
1
1
Full thickness (Third Degree) Burn
1
1
Viral Infection
1
1
Hemorrhage/Bleeding
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
-
-