21 CFR 886.4100 — Apparatus, Cautery, Radiofrequency, Battery-Powered

Ophthalmic (OP) · Part 886 Subpart E—Surgical Devices · § 886.4100

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.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
HQQApparatus, Cautery, Radiofrequency, Battery-Powered233rd Party
HQRApparatus, Cautery, Radiofrequency, Ac-Powered2113rd Party
NCRApparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered233rd Party
PULApparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered24
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