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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 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
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
ELITE ELECTROMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ERCHONIA MEDICAL
  SUBSTANTIALLY EQUIVALENT 5
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

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