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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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.
Product CodeNHN
Regulation Number 890.5500
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
ELITE ELECTROMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ERCHONIA MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
INTERNATIONAL MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL LASER SYSTEMS INC
  SUBSTANTIALLY EQUIVALENT 1
MEDX
  SUBSTANTIALLY EQUIVALENT 2
MERIDIAN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROLIGHT CORPORATION OF AMERICA
  SUBSTANTIALLY EQUIVALENT 1
SOLICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

-
-