Section 886.4250 - Ophthalmic electrolysis unit(a)Identification. An ophthalmic electrolysis unit is an AC-powered or battery-powered device intended to destroy ocular hair follicles by applying a galvanic electrical current.(b)Classification.(1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9 .(2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9 .55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38813 , July 25, 2001; 84 FR 71817 , Dec. 30, 2019