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

21 CFR 886.4100: Radiofrequency electrosurgical cautery apparatus.

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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. A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.

(b) Classification. Class II.

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

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