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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
APPLIED BIOPHOTONICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
ASPEN LASER SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
AVANT WELLNESS SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
AVICENNA LASER TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING HUATAI HEALTHCARE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOLASE TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOLIGHT AB
  SUBSTANTIALLY EQUIVALENT 1
BIOPHOTAS, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOPHOTAS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOREMEDI THERAPEUTIC SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
CHOGQING YUHE MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CRYSTAL MEDTECH, LLC
  SUBSTANTIALLY EQUIVALENT 1
CURAE'LASE INC.
  SUBSTANTIALLY EQUIVALENT 1
CYNOSURE, INC.
  SUBSTANTIALLY EQUIVALENT 2
CYTONSYS INC
  SUBSTANTIALLY EQUIVALENT 1
DYNATRONICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
EAS CONSULTING GROUP LLC
  SUBSTANTIALLY EQUIVALENT 1
EL.EN. ELECTRONIC ENGINEERING SPA
  SUBSTANTIALLY EQUIVALENT 1
ELTECH S.R.L
  SUBSTANTIALLY EQUIVALENT 1
ELTECH, S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN GAUNYING ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
FUTURE DEVICE AND TECHNOLOGY, INC
  SUBSTANTIALLY EQUIVALENT 1
GENESIS HEALTH LIGHT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
H.V.R., INC.
  SUBSTANTIALLY EQUIVALENT 1
HARBIN QUANKE MEDI-TECHNICAL DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEALTHLIGHT, LLC
  SUBSTANTIALLY EQUIVALENT 1
HILL LABORATORIES CO.
  SUBSTANTIALLY EQUIVALENT 2
HOME SKINOVATIONS LTD.
  SUBSTANTIALLY EQUIVALENT 3
IN LIGHT WELLNESS SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE MED, INC.
  SUBSTANTIALLY EQUIVALENT 1
JEISYS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
LASERSTIM, INC.
  SUBSTANTIALLY EQUIVALENT 1
LED INTELLECTUAL PROPERTIES LLC
  SUBSTANTIALLY EQUIVALENT 1
LED INTELLECTUAL PROPERTIES, LLC
  SUBSTANTIALLY EQUIVALENT 2
LIGHT TREE VENTURES EUROPE B.V.
  SUBSTANTIALLY EQUIVALENT 1
LITECURE, LLC
  SUBSTANTIALLY EQUIVALENT 2
LIVETEC GMBH
  SUBSTANTIALLY EQUIVALENT 3
LTBIO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LUMANOSITY, INC
  SUBSTANTIALLY EQUIVALENT 1
LUTRONIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LZR7, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL LASERS MANUFACTURER INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIDIAN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEUROLUMEN, LLC
  SUBSTANTIALLY EQUIVALENT 2
PALOMAR MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHAROS LIFE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PHOENIX THERA-LASE SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
POWERMEDIC APS
  SUBSTANTIALLY EQUIVALENT 1
PRIME HERBS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PRO MEDICAL SUPPLIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
QUANTUM DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
REIMERS AND JANSSEN GMBH
  SUBSTANTIALLY EQUIVALENT 2
SEDATELEC
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOMETECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STELLAR LASERS
  SUBSTANTIALLY EQUIVALENT 1
TECHNOLOGICAL MEDICAL ADVANCMENTS, INC. (TMA)
  SUBSTANTIALLY EQUIVALENT 1
TEXAS APPLIED BIOMEDICAL SERVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
THERASAGE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
UNITED INTEGRATED SERVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
USA LASER BIOTECH INC.
  SUBSTANTIALLY EQUIVALENT 4
VARAYA PHOTOCEUTICALS, LLC
  SUBSTANTIALLY EQUIVALENT 2
VEVAZZ, LLC
  SUBSTANTIALLY EQUIVALENT 1
WELLQUEST INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
WELLRAY MEDICAL LASER, INC.
  SUBSTANTIALLY EQUIVALENT 1
WS FAR IR MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YA-MAN LTD
  SUBSTANTIALLY EQUIVALENT 1
YOLO MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
YORK BIOMEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER MEDIZINSYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 2 2
2016 2 2
2017 12 12
2018 1 1
2019 7 7
2020 5 5
2021 5 5
2022 2 2
2023 15 15
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Excessive Heating 16 16
Adverse Event Without Identified Device or Use Problem 9 9
Patient-Device Incompatibility 7 7
Overheating of Device 4 4
Device Operates Differently Than Expected 3 3
Improper or Incorrect Procedure or Method 3 3
Use of Device Problem 2 2
Insufficient Information 2 2
Labelling, Instructions for Use or Training Problem 1 1
Noise, Audible 1 1
Temperature Problem 1 1
Break 1 1
Defective Device 1 1
Thermal Decomposition of Device 1 1
Electrical Shorting 1 1
Device-Device Incompatibility 1 1
Device Emits Odor 1 1
Smoking 1 1
Melted 1 1
Therapeutic or Diagnostic Output Failure 1 1
Electrical /Electronic Property Problem 1 1
Power Problem 1 1
Device Operational Issue 1 1
Fire 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burning Sensation 13 13
No Known Impact Or Consequence To Patient 6 6
Pain 5 5
Rash 5 5
No Clinical Signs, Symptoms or Conditions 4 4
Headache 3 3
Partial thickness (Second Degree) Burn 3 3
Dizziness 3 3
Unspecified Infection 2 2
Inflammation 2 2
Radiation Burn 2 2
Burn(s) 2 2
Keratitis 2 2
Nausea 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Numbness 2 2
Burn, Thermal 2 2
Ambulation Difficulties 1 1
Superficial (First Degree) Burn 1 1
Skin Inflammation 1 1
Palpitations 1 1
Bruise/Contusion 1 1
Loss of Range of Motion 1 1
Red Eye(s) 1 1
Swelling 1 1
Blurred Vision 1 1
Cellulitis 1 1
Death 1 1
Dyspnea 1 1
Fatigue 1 1
Itching Sensation 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Inadequate Pain Relief 1 1
Sore Throat 1 1
Reaction 1 1
Full thickness (Third Degree) Burn 1 1
Radiation Exposure, Unintended 1 1
Convulsion/Seizure 1 1
Swollen Lymph Nodes/Glands 1 1
Unspecified Respiratory Problem 1 1
Unspecified Eye / Vision Problem 1 1
Blister 1 1
Skin Burning Sensation 1 1
Skin Inflammation/ Irritation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cutera Inc II Nov-09-2010
2 Inlightened Partners LLC III Jun-24-2021
3 LED Technologies, LLC II Apr-28-2016
4 Pivotal Health Solutions II Mar-06-2015
5 Quasar Bio-Tech, Inc. dba Silver Bay LLC II Dec-12-2012
6 Suarez Corporation Industries II Aug-07-2009
7 THOR Photomedicine Ltd II Feb-01-2024
8 Thor Photomedicine Ltd II Dec-01-2023
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