Medical ultraviolet water purifier.

(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. [45 FR 69682, Oct. 21, 1980, as amended at 83 FR 25915, June 5, 2018]