21 CFR §880.6710
Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
- (a)Identification. A medical ultraviolet water purifier is a device intended for medical purposes that is used to destroy bacteria in water by exposure to ultraviolet radiation.
- (b)Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E, of this chapter subject to the limitations in § 880.9.