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 system, laser, photodynamic therapy
Product CodeMVF
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
0 0 1 1 0 2

MDR Year MDR Reports MDR Events
2020 4 4
2021 4 4
2022 2 2
2023 4 4
2024 5 5
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7 7
Insufficient Information 3 3
Device Operational Issue 1 1
Output Problem 1 1
Patient-Device Incompatibility 1 1
Patient Device Interaction Problem 1 1
Use of Device Problem 1 1
Fracture 1 1
Improper Chemical Reaction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burning Sensation 5 5
Low Blood Pressure/ Hypotension 5 5
Pain 3 3
Caustic/Chemical Burns 3 3
Hypersensitivity/Allergic reaction 2 2
Reaction 2 2
Abdominal Pain 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Syncope/Fainting 1 1
No Code Available 1 1
Dry Eye(s) 1 1
Blood Loss 1 1
Scarring 1 1
Itching Sensation 1 1
Confusion/ Disorientation 1 1
Epistaxis 1 1
Irritation 1 1
Fever 1 1
Chills 1 1
Burn(s) 1 1
Swelling 1 1
Discomfort 1 1
Erythema 1 1
Vomiting 1 1
Viral Infection 1 1
Hair Loss 1 1
Dyspnea 1 1
Swelling/ Edema 1 1
Stenosis 1 1
Partial thickness (Second Degree) Burn 1 1
Radiation Burn 1 1
Loss of consciousness 1 1
Eye Pain 1 1

-
-