21 C.F.R. § 880.6320

AC-powered medical examination light.

Last amended: 2016Year: 2026Length: 80 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 880.6320 (2026)

(a) Identification. An AC-powered medical examination light is an AC-powered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. [45 FR 69682, Oct. 21, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38806, July 25, 2001]
Cross-references to the CFR
880.9.
21 C.F.R. § 880.6320: AC-powered medical examination light. | Justis AI