OHW

Burr, Corneal, Battery Powered, Rust Ring Removal

Product code: OHW
Device name: Burr, Corneal, Battery Powered, Rust Ring Removal
Device class: Class 1
21 CFR: 21 CFR 886.4070
Medical specialty: Ophthalmic
Marketing pathway: 510(K) Exempt

FDA classification definition

A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye and is class I exempt when intended only for rust ring removal.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: OHW

Classification and pathway per current FDA publications. Data from openFDA (CC0).