• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device powered light based non-laser non-thermal instrument with non-heating effect for adjunctive use in pain therapy
Regulation Description Infrared lamp.
Definition A light based non-laser device that emits energy in 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.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeNHN
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Neurotherapueutic Devices Branch (PNDB)
Submission Type 510(k)
Regulation Number 890.5500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Guidance Document
  • Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices
Third Party Review Not Third Party Eligible
-
-