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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
unit, neonatal phototherapy
Product Code
LBI
Regulation Number
880.5700
Device Class
2
Premarket Reviews
Manufacturer
Decision
AVALON BIOMEDICAL (SHENZHEN) LIMITED
SUBSTANTIALLY EQUIVALENT
1
BISTOS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
LITTLE SPARROWS TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
6
6
2020
6
6
2021
2
2
2022
8
8
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
3
3
Device Dislodged or Dislocated
3
3
Device Fell
3
3
Use of Device Problem
3
3
Material Twisted/Bent
3
3
Detachment of Device or Device Component
3
3
Break
2
2
Appropriate Term/Code Not Available
2
2
Dent in Material
2
2
Failure to Power Up
2
2
Overheating of Device
2
2
Output Problem
1
1
Device Tipped Over
1
1
Structural Problem
1
1
Sparking
1
1
Material Frayed
1
1
Crack
1
1
Patient-Device Incompatibility
1
1
Component Missing
1
1
Loss of Power
1
1
Loss of or Failure to Bond
1
1
Smoking
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
13
13
No Known Impact Or Consequence To Patient
5
5
Skin Irritation
3
3
No Consequences Or Impact To Patient
2
2
Skin Inflammation/ Irritation
1
1
Burn, Thermal
1
1
Insufficient Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Lumitex Inc
II
Jan-31-2020
-
-