Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
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 Back to Search Results
Device light, examination, medical, battery powered
Product CodeKYT
Regulation Number 880.6350
Device Class 1

MDR Year MDR Reports MDR Events
2015 1 1
2016 1 1
2018 1 1
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fire 2 2
Noise, Audible 2 2
Charred 1 1
Overheating of Device 1 1
Excessive Heating 1 1
Sparking 1 1
Unexpected Shutdown 1 1
Smoking 1 1
Thermal Decomposition of Device 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Partial thickness (Second Degree) Burn 2 2
No Clinical Signs, Symptoms or Conditions 1 1
Scarring 1 1
Blister 1 1
No Known Impact Or Consequence To Patient 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DermLite LLC II May-04-2023
-
-