21 CFR §880.6350

1. (a)Identification. A battery-powered medical examination light is a battery-powered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.
2. (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. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.