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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
Product CodeILY
Regulation Number 890.5500
Device Class 2


Premarket Reviews
ManufacturerDecision
AESTHETIC TECHNOLOGY LTD
  SUBSTANTIALLY EQUIVALENT 1
CHOGQING YUHE MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CRYSTAL MEDTECH, LLC
  SUBSTANTIALLY EQUIVALENT 1
HEALTHLIGHT, LLC
  SUBSTANTIALLY EQUIVALENT 1
VEVAZZ, LLC
  SUBSTANTIALLY EQUIVALENT 1
WELLRAY MEDICAL LASER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 12 12
2018 1 1
2019 7 7
2020 5 5
2021 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Patient-Device Incompatibility 7 7
Overheating of Device 4 4
Improper or Incorrect Procedure or Method 2 2
Device Operates Differently Than Expected 2 2
Device Operational Issue 1 1
Electrical Shorting 1 1
Power Problem 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Noise, Audible 1 1
Defective Device 1 1
Smoking 1 1
Break 1 1
Thermal Decomposition of Device 1 1
Electrical /Electronic Property Problem 1 1
Fire 1 1
Melted 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 6 6
Rash 5 5
Pain 4 4
Partial thickness (Second Degree) Burn 3 3
Numbness 2 2
Burn, Thermal 2 2
Dizziness 2 2
Headache 2 2
Radiation Burn 2 2
Keratitis 2 2
Nausea 1 1
Fatigue 1 1
Unspecified Infection 1 1
Inflammation 1 1
Itching Sensation 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Inadequate Pain Relief 1 1
Reaction 1 1
Loss of Range of Motion 1 1
Blurred Vision 1 1
Burning Sensation 1 1
Ambulation Difficulties 1 1
Skin Inflammation 1 1
Palpitations 1 1
Radiation Exposure, Unintended 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Inlightened Partners LLC III Jun-24-2021
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