|Product||powered light based non-laser non-thermal instrument with non-heating effect for adjunctive use in pain therapy|
|Regulation Description||Infrared lamp.|
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.
General Optical Products / Medical
|Radiation Safety Report Type Required?
|Annual Reports Required?
|Applicable Performance Standard(s)
No standard applicable. General Radiological Health requirements apply. [1000-1005]|
|Recognized Consensus Standard
- Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices