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 powered light based laser non-thermal instrument with non-heating effect for adjunctive use in pain therapy
Regulation Description Infrared lamp.
Definition A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. This device emits energy in the infrared or other wavelengths, provides non-heating and non-thermal effect, and is indicated for adjunctive use in pain therapy or related indication. It does not provide therapeutic topical heating. The classification regulation for infrared lamps describes a device that emits energy in the infrared wavelength to provide topical heating and that is not limited to adjunctive use.
Product CodeNHN
Regulation Number 890.5500
Device Class 2


Premarket Reviews
ManufacturerDecision
DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDA
  SUBSTANTIALLY EQUIVALENT 1
DMC IMPORTAÇÃO E EXPORTAÇÃO DE EQUIPAMENTOS LTDA
  SUBSTANTIALLY EQUIVALENT 1
ERCHONIA CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
MULTI RADIANCE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WUHAN GUANGDUN TECHNOLOGY CO.,LTD..
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 2
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
High Blood Pressure/ Hypertension 1 2
Fatigue 1 2
Dizziness 1 2
Skin Discoloration 1 1
Neck Pain 1 2
Scar Tissue 1 1

-
-