CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 886—OPHTHALMIC DEVICES > SUBPART E—Surgical Devices (§886.4070 to §886.4855) > 886.4250—Ophthalmic electrolysis unit.

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. Class I for the battery-powered device. Class II for the AC-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.

Code of Federal Regulations

[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38813, July 25, 2001]