21 C.F.R. § 886.4100
Radiofrequency electrosurgical cautery apparatus.
Cite as 21 C.F.R. § 886.4100 (2026)
(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.