(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 69682-69737, Oct. 21, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38806, July 25, 2001]