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U.S. Department of Health and Human Services

Radiation Emitting Electronic Product Codes
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Productpowered light based laser non-thermal instrument with non-heating effect for adjunctive use in pain therapy
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 Medical Laser Products
Product CodeNHN
Radiation Type Optical
Radiation Safety Report Type Required? Product
Annual Reports Required? Yes
Regulation Number 890.5500
Applicable Performance Standard(s) Laser products. [1040.10]
Specific purpose laser products. [1040.11]

Guidance Document

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