21 C.F.R. § 886.4100 Radiofrequency electrosurgical cautery apparatus.
Title 21 - Food and Drugs
(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.
Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart E—Surgical Devices
§ 886.4100 Radiofrequency electrosurgical cautery apparatus.