21 C.F.R. § 890.5500

Infrared lamp.

Last amended: 2019Year: 2026Length: 82 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 890.5500 (2026)

(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. [48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]
Cross-references to the CFR
890.9.
21 C.F.R. § 890.5500: Infrared lamp. | Justis AI