Title 21: Food and Drugs
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/ PART 890 - PHYSICAL MEDICINE DEVICES
/ Subpart F - Physical Medicine Therapeutic Devices / § 890.5500 Infrared lamp.
§ 890.5500 Infrared lamp.
(a) Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.
(b) Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.