Product code OHX

Device name

Burr, Corneal, Ac-Powered, Rust Ring Removal

Medical specialty

Ophthalmic

Device class

1

Regulation number

886.4070

Review panel

OP

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset