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Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 886.4250: Ophthalmic electrolysis unit.

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Where this section sits in the code
  1. Title 21—Food and Drugs
  2. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  3. SUBCHAPTER H—MEDICAL DEVICES
  4. PART 886—OPHTHALMIC DEVICES
  5. Subpart E—Surgical Devices

(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.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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