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U.S. Department of Health and Human Services

Radiation Emitting Electronic Product Codes

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Productpowered light based non-laser non-thermal instrument with non-heating effect for adjunctive use in pain therapy
Regulation DescriptionInfrared 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 Description Physical Medicine General Optical Products / Medical
Product CodeNHN
Radiation Type Optical
Radiation Safety Report Type Required? None
Annual Reports Required? No
Regulation Number 890.5500
Applicable Performance Standard(s) No standard applicable. General Radiological Health requirements apply. [1000-1005]

Recognized Consensus Standard
Guidance Document

  • Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices